www.pharmalex.com
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Submitted URL: https://checkpoint.url-protection.com/v1/url?o=https://www.pharmalex.com/integrated-product-development/&g=ZDA2Yzc0MTYxMGM2NDVjYg==&h=...
Effective URL: https://www.pharmalex.com/integrated-product-development/
Submission: On August 18 via api from BE — Scanned from DE
Effective URL: https://www.pharmalex.com/integrated-product-development/
Submission: On August 18 via api from BE — Scanned from DE
Form analysis
6 forms found in the DOMGET https://www.pharmalex.com/
<form class="searchform" role="search" method="get" action="https://www.pharmalex.com/">
<input type="text" class="field searchform-s" name="s" value="" placeholder="Type and hit enter …">
<input type="submit" class="assistive-text searchsubmit" value="Go!">
<a href="#go" id="trigger-overlay" class="submit">Search</a>
</form>
https://www.pharmalex.com/
<form class="mega-search mega-search-open" role="search" action="https://www.pharmalex.com/">
<span class="dashicons dashicons-search search-icon"></span>
<input type="submit" value="Search">
<input type="text" aria-label="Search..." data-placeholder="Search..." placeholder="Search..." name="s">
</form>
POST /integrated-product-development/#wpcf7-f14819-p16336-o3
<form action="/integrated-product-development/#wpcf7-f14819-p16336-o3" method="post" class="wpcf7-form init wpcf7-acceptance-as-validation" novalidate="novalidate" data-status="init">
<div style="display: none;">
<input type="hidden" name="_wpcf7" value="14819">
<input type="hidden" name="_wpcf7_version" value="5.6.1">
<input type="hidden" name="_wpcf7_locale" value="de_DE">
<input type="hidden" name="_wpcf7_unit_tag" value="wpcf7-f14819-p16336-o3">
<input type="hidden" name="_wpcf7_container_post" value="16336">
<input type="hidden" name="_wpcf7_posted_data_hash" value="">
<input type="hidden" name="_wpcf7cf_hidden_group_fields" value="["state"]">
<input type="hidden" name="_wpcf7cf_hidden_groups" value="["countiesgroup"]">
<input type="hidden" name="_wpcf7cf_visible_groups" value="[]">
<input type="hidden" name="_wpcf7cf_repeaters" value="[]">
<input type="hidden" name="_wpcf7cf_steps" value="{}">
<input type="hidden" name="_wpcf7cf_options"
value="{"form_id":14819,"conditions":[{"then_field":"countiesgroup","and_rules":[{"if_field":"country","operator":"equals","if_value":"United States"}]}],"settings":{"animation":"yes","animation_intime":200,"animation_outtime":200,"conditions_ui":"normal","notice_dismissed":false,"notice_dismissed_rollback-cf7-5.5.1":true}}">
<input type="hidden" name="_wpcf7_recaptcha_response" value="">
</div>
<p><span class="wpcf7-form-control-wrap" data-name="first-name"><input type="text" name="first-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="First Name (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="last-name"><input type="text" name="last-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="Last Name (Mandatory)"></span><span class="wpcf7-form-control-wrap" data-name="e-mail"><input type="email" name="e-mail" value="" size="40"
class="wpcf7-form-control wpcf7-text wpcf7-email wpcf7-validates-as-required wpcf7-validates-as-email input_field" id="email" aria-required="true" aria-invalid="false" placeholder="Email (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="phone"><input type="text" name="phone" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true" aria-invalid="false"
placeholder="Telephone Number (Mandatory)"></span>
</p>
<p><span class="wpcf7-form-control-wrap" data-name="country"><select name="country" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">Where are you located?</option>
<option value="Afghanistan">Afghanistan</option>
<option value="Albania">Albania</option>
<option value="Algeria">Algeria</option>
<option value="Armenia">Armenia</option>
<option value="Argentina">Argentina</option>
<option value="Austria">Austria</option>
<option value="Australia">Australia</option>
<option value="Azerbaijan">Azerbaijan</option>
<option value="Bangladesh">Bangladesh</option>
<option value="Belarus">Belarus</option>
<option value="Belgium">Belgium</option>
<option value="Bosnia and Herzegovina">Bosnia and Herzegovina</option>
<option value="Bolivia">Bolivia</option>
<option value="Brazil">Brazil</option>
<option value="British Virgin Islands">British Virgin Islands</option>
<option value="Bulgaria">Bulgaria</option>
<option value="Canada">Canada</option>
<option value="Chile">Chile</option>
<option value="China">China</option>
<option value="Colombia">Colombia</option>
<option value="Costa Rica">Costa Rica</option>
<option value="Croatia">Croatia</option>
<option value="Cuba">Cuba</option>
<option value="Cyprus">Cyprus</option>
<option value="Czech Republic">Czech Republic</option>
<option value="Denmark">Denmark</option>
<option value="Dominican Republic">Dominican Republic</option>
<option value="Ecuador">Ecuador</option>
<option value="El Salvador">El Salvador</option>
<option value="Estonia">Estonia</option>
<option value="Egypt">Egypt</option>
<option value="Spain">Spain</option>
<option value="Finland">Finland</option>
<option value="France">France</option>
<option value="Georgia">Georgia</option>
<option value="Germany">Germany</option>
<option value="Ghana">Ghana</option>
<option value="Greece">Greece</option>
<option value="Honduras">Honduras</option>
<option value="Hungary">Hungary</option>
<option value="Iceland">Iceland</option>
<option value="India">India</option>
<option value="Indonesia">Indonesia</option>
<option value="Israel">Israel</option>
<option value="Ireland">Ireland</option>
<option value="Iraq">Iraq</option>
<option value="Iran, Islamic Republic of">Iran, Islamic Republic of</option>
<option value="Isle of Man">Isle of Man</option>
<option value="Italy">Italy</option>
<option value="Jamaica">Jamaica</option>
<option value="Japan">Japan</option>
<option value="Jordan">Jordan</option>
<option value="Kazakhstan">Kazakhstan</option>
<option value="Korea (North)">Korea (North)</option>
<option value="Korea (South)">Korea (South)</option>
<option value="Kuwait">Kuwait</option>
<option value="Latvia">Latvia</option>
<option value="Lebanon">Lebanon</option>
<option value="Liechtenstein">Liechtenstein</option>
<option value="Lithuania">Lithuania</option>
<option value="Luxemburg">Luxemburg</option>
<option value="Macao">Macao</option>
<option value="Macedonia, Republic of">Macedonia, Republic of</option>
<option value="Malta">Malta</option>
<option value="Malaysia">Malaysia</option>
<option value="Marshall Islands">Marshall Islands</option>
<option value="Mexico">Mexico</option>
<option value="Morocco">Morocco</option>
<option value="Monaco">Monaco</option>
<option value="Moldova">Moldova</option>
<option value="Montenegro">Montenegro</option>
<option value="Myanmar">Myanmar</option>
<option value="Namibia">Namibia</option>
<option value="Netherlands">Netherlands</option>
<option value="New Zealand">New Zealand</option>
<option value="Norway">Norway</option>
<option value="Oman">Oman</option>
<option value="Pakistan">Pakistan</option>
<option value="Palestinian Territory">Palestinian Territory</option>
<option value="Panama">Panama</option>
<option value="Paraguay">Paraguay</option>
<option value="Peru">Peru</option>
<option value="Philippines">Philippines</option>
<option value="Poland">Poland</option>
<option value="Portugal">Portugal</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Qatar">Qatar</option>
<option value="Romania">Romania</option>
<option value="Serbia">Serbia</option>
<option value="Russian Federation">Russian Federation</option>
<option value="Saudi Arabia">Saudi Arabia</option>
<option value="Singapore">Singapore</option>
<option value="Slovenia">Slovenia</option>
<option value="Slovakia">Slovakia</option>
<option value="South Africa">South Africa</option>
<option value="Sri Lanka">Sri Lanka</option>
<option value="Sudan">Sudan</option>
<option value="Sweden">Sweden</option>
<option value="Switzerland">Switzerland</option>
<option value="Syrian Arab Republic (Syria)">Syrian Arab Republic (Syria)</option>
<option value="Taiwan, Republic of China">Taiwan, Republic of China</option>
<option value="Thailand">Thailand</option>
<option value="Tunisia">Tunisia</option>
<option value="Turkey">Turkey</option>
<option value="Ukraine">Ukraine</option>
<option value="United Arab Emirates">United Arab Emirates</option>
<option value="United Kingdom">United Kingdom</option>
<option value="United States">United States</option>
<option value="Uruguay">Uruguay</option>
<option value="Venezuela (Bolivarian Republic)">Venezuela (Bolivarian Republic)</option>
<option value="Vietnam">Vietnam</option>
</select></span></p>
<div data-id="countiesgroup" data-orig_data_id="countiesgroup" data-class="wpcf7cf_group" style="height: auto;" class="wpcf7cf-hidden">
<p>Select your state: </p>
<p>
<span class="wpcf7-form-control-wrap" data-name="state"><select name="state" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">---</option>
<option value="Alabama">Alabama</option>
<option value="Alaska">Alaska</option>
<option value="Arizona">Arizona</option>
<option value="Arkansas">Arkansas</option>
<option value="California">California</option>
<option value="Colorado">Colorado</option>
<option value="Connecticut">Connecticut</option>
<option value="Delaware">Delaware</option>
<option value="District of Columbia">District of Columbia</option>
<option value="Florida">Florida</option>
<option value="Georgia">Georgia</option>
<option value="Hawaii">Hawaii</option>
<option value="Idaho">Idaho</option>
<option value="Illinois">Illinois</option>
<option value="Indiana">Indiana</option>
<option value="Iowa">Iowa</option>
<option value="Kansas">Kansas</option>
<option value="Kentucky">Kentucky</option>
<option value="Louisiana">Louisiana</option>
<option value="Maine">Maine</option>
<option value="Maryland">Maryland</option>
<option value="Massachusetts">Massachusetts</option>
<option value="Michigan">Michigan</option>
<option value="Minnesota">Minnesota</option>
<option value="Mississippi">Mississippi</option>
<option value="Missouri">Missouri</option>
<option value="Montana">Montana</option>
<option value="Nebraska">Nebraska</option>
<option value="Nevada">Nevada</option>
<option value="New Hampshire">New Hampshire</option>
<option value="New Jersey">New Jersey</option>
<option value="New Mexico">New Mexico</option>
<option value="New York">New York</option>
<option value="North Carolina">North Carolina</option>
<option value="North Dakota">North Dakota</option>
<option value="Ohio">Ohio</option>
<option value="Oklahoma">Oklahoma</option>
<option value="Oregon">Oregon</option>
<option value="Pennsylvania">Pennsylvania</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Rhode Island">Rhode Island</option>
<option value="South Carolina">South Carolina</option>
<option value="South Dakota">South Dakota</option>
<option value="Tennessee">Tennessee</option>
<option value="Texas">Texas</option>
<option value="Utah">Utah</option>
<option value="Vermont">Vermont</option>
<option value="Virginia">Virginia</option>
<option value="Washington">Washington</option>
<option value="West Virginia">West Virginia</option>
<option value="Wisconsin">Wisconsin</option>
<option value="Wyoming">Wyoming</option>
</select></span>
</p>
</div>
<p style="margin-bottom: 10px;font-size: 11px;color:#fff"><span class="wpcf7-form-control-wrap" data-name="gdpr-consent"><span class="wpcf7-form-control wpcf7-acceptance"><span class="wpcf7-list-item"><label><input type="checkbox"
name="gdpr-consent" value="1" aria-invalid="false"><span class="wpcf7-list-item-label">Please tick this box to agree to our Privacy Policy</span></label></span></span></span></p>
<p style="margin-bottom: 10px;font-size: 11px;color:#fff"><span class="wpcf7-form-control-wrap" data-name="marketing-materials"><span class="wpcf7-form-control wpcf7-checkbox"><span class="wpcf7-list-item first last"><label><input type="checkbox"
name="marketing-materials[]" value="Please tick this box if you agree to periodic updates from PharmaLex"><span class="wpcf7-list-item-label">Please tick this box if you agree to periodic updates from
PharmaLex</span></label></span></span></span>. <br>If you do not wish to receive any communication from us, you may unsubscribe at any time.</p>
<p><span id="wpcf7-62f10defc7691-wrapper" class="wpcf7-form-control-wrap county-wrap"><label for="wpcf7-62f10defc7691-field" class="hp-message">Please leave this field empty.</label><input id="wpcf7-62f10defc7691-field"
class="wpcf7-form-control wpcf7-text" type="text" name="county" value="" size="40" tabindex="-1" autocomplete="new-password"></span></p>
<span class="wpcf7-form-control-wrap recaptcha"><span data-sitekey="6Ld5IU0UAAAAACrCkbMzml_RNn203llY5LCRm-cW" class="wpcf7-form-control g-recaptcha wpcf7-recaptcha">
<div style="width: 304px; height: 78px;">
<div><iframe title="reCAPTCHA"
src="https://www.recaptcha.net/recaptcha/api2/anchor?ar=1&k=6Ld5IU0UAAAAACrCkbMzml_RNn203llY5LCRm-cW&co=aHR0cHM6Ly93d3cucGhhcm1hbGV4LmNvbTo0NDM.&hl=en&v=mq0-U1BHZ5YTcoDC-CvsLPNc&size=normal&cb=y6n60x1vswjb"
width="304" height="78" role="presentation" name="a-v0pr36nj3b0" frameborder="0" scrolling="no" sandbox="allow-forms allow-popups allow-same-origin allow-scripts allow-top-navigation allow-modals allow-popups-to-escape-sandbox"></iframe>
</div><textarea id="g-recaptcha-response" name="g-recaptcha-response" class="g-recaptcha-response"
style="width: 250px; height: 40px; border: 1px solid rgb(193, 193, 193); margin: 10px 25px; padding: 0px; resize: none; display: none;"></textarea>
</div>
</span>
<noscript>
<div class="grecaptcha-noscript">
<iframe src="https://www.recaptcha.net/recaptcha/api/fallback?k=6Ld5IU0UAAAAACrCkbMzml_RNn203llY5LCRm-cW" frameborder="0" scrolling="no" width="310" height="430">
</iframe>
<textarea name="g-recaptcha-response" rows="3" cols="40" placeholder="reCaptcha Response Here"> </textarea>
</div>
</noscript>
</span>
<p><input type="submit" value="Send Request" class="wpcf7-form-control has-spinner wpcf7-submit"><span class="wpcf7-spinner"></span>
</p>
<div class="wpcf7-response-output" aria-hidden="true"></div>
<p style="margin-top: 20px;margin-bottom: 10px;font-size: 11px;color:#fff"> Click here to view our <a href="" "https:="" www.pharmalex.com="" data-protection="" "="">Privacy Policy.</a></p>
<p style="display: none !important;"><label>Δ<textarea name="_wpcf7_ak_hp_textarea" cols="45" rows="8" maxlength="100"></textarea></label><input type="hidden" id="ak_js_3" name="_wpcf7_ak_js" value="1660823408100">
<script>
document.getElementById("ak_js_3").setAttribute("value", (new Date()).getTime());
</script>
</p><input type="hidden" class="wpcf7-pum" value="{"closepopup":false,"closedelay":0,"openpopup":false,"openpopup_id":0}">
</form>
POST /integrated-product-development/#wpcf7-f124-o1
<form action="/integrated-product-development/#wpcf7-f124-o1" method="post" class="wpcf7-form init wpcf7-acceptance-as-validation" novalidate="novalidate" data-status="init">
<div style="display: none;">
<input type="hidden" name="_wpcf7" value="124">
<input type="hidden" name="_wpcf7_version" value="5.6.1">
<input type="hidden" name="_wpcf7_locale" value="de_DE">
<input type="hidden" name="_wpcf7_unit_tag" value="wpcf7-f124-o1">
<input type="hidden" name="_wpcf7_container_post" value="0">
<input type="hidden" name="_wpcf7_posted_data_hash" value="">
<input type="hidden" name="_wpcf7cf_hidden_group_fields" value="["state"]">
<input type="hidden" name="_wpcf7cf_hidden_groups" value="["countiesgroup"]">
<input type="hidden" name="_wpcf7cf_visible_groups" value="[]">
<input type="hidden" name="_wpcf7cf_repeaters" value="[]">
<input type="hidden" name="_wpcf7cf_steps" value="{}">
<input type="hidden" name="_wpcf7cf_options"
value="{"form_id":124,"conditions":[{"then_field":"countiesgroup","and_rules":[{"if_field":"country","operator":"equals","if_value":"United States"}]}],"settings":{"animation":"yes","animation_intime":200,"animation_outtime":200,"conditions_ui":"normal","notice_dismissed":false,"notice_dismissed_rollback-cf7-5.5.1":true}}">
<input type="hidden" name="_wpcf7_recaptcha_response" value="">
</div>
<div class="wpcf7-response-output" aria-hidden="true"></div>
<p><strong>Please DO NOT send us event/conference information.<br> We will not respond and these will be deleted immediately.</strong>
</p>
<p><span class="wpcf7-form-control-wrap" data-name="first-name"><input type="text" name="first-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="Your First Name (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="last-name"><input type="text" name="last-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="Your Last Name (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="e-mail"><input type="email" name="e-mail" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-email wpcf7-validates-as-required wpcf7-validates-as-email input_field" id="email"
aria-required="true" aria-invalid="false" placeholder="Your Email (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="phone"><input type="text" name="phone" value="" size="40" class="wpcf7-form-control wpcf7-text input_field" id="your-name" aria-invalid="false" placeholder="Your Telephone Number"></span><br>
<span class="wpcf7-form-control-wrap" data-name="message"><textarea name="message" cols="40" rows="4" class="wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required input_field" id="message" aria-required="true" aria-invalid="false"
placeholder="Your message (Mandatory)"></textarea></span>
</p>
<p><span class="wpcf7-form-control-wrap" data-name="country"><select name="country" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">Where are you located?</option>
<option value="Afghanistan">Afghanistan</option>
<option value="Albania">Albania</option>
<option value="Algeria">Algeria</option>
<option value="Armenia">Armenia</option>
<option value="Argentina">Argentina</option>
<option value="Austria">Austria</option>
<option value="Australia">Australia</option>
<option value="Azerbaijan">Azerbaijan</option>
<option value="Bangladesh">Bangladesh</option>
<option value="Belarus">Belarus</option>
<option value="Belgium">Belgium</option>
<option value="Bosnia and Herzegovina">Bosnia and Herzegovina</option>
<option value="Bolivia">Bolivia</option>
<option value="Brazil">Brazil</option>
<option value="British Virgin Islands">British Virgin Islands</option>
<option value="Bulgaria">Bulgaria</option>
<option value="Canada">Canada</option>
<option value="Chile">Chile</option>
<option value="China">China</option>
<option value="Colombia">Colombia</option>
<option value="Costa Rica">Costa Rica</option>
<option value="Croatia">Croatia</option>
<option value="Cuba">Cuba</option>
<option value="Cyprus">Cyprus</option>
<option value="Czech Republic">Czech Republic</option>
<option value="Denmark">Denmark</option>
<option value="Dominican Republic">Dominican Republic</option>
<option value="Ecuador">Ecuador</option>
<option value="El Salvador">El Salvador</option>
<option value="Estonia">Estonia</option>
<option value="Egypt">Egypt</option>
<option value="Spain">Spain</option>
<option value="Finland">Finland</option>
<option value="France">France</option>
<option value="Georgia">Georgia</option>
<option value="Germany">Germany</option>
<option value="Ghana">Ghana</option>
<option value="Greece">Greece</option>
<option value="Honduras">Honduras</option>
<option value="Hungary">Hungary</option>
<option value="Iceland">Iceland</option>
<option value="India">India</option>
<option value="Indonesia">Indonesia</option>
<option value="Israel">Israel</option>
<option value="Ireland">Ireland</option>
<option value="Iraq">Iraq</option>
<option value="Iran, Islamic Republic of">Iran, Islamic Republic of</option>
<option value="Isle of Man">Isle of Man</option>
<option value="Italy">Italy</option>
<option value="Jamaica">Jamaica</option>
<option value="Japan">Japan</option>
<option value="Jordan">Jordan</option>
<option value="Kazakhstan">Kazakhstan</option>
<option value="Korea (North)">Korea (North)</option>
<option value="Korea (South)">Korea (South)</option>
<option value="Kuwait">Kuwait</option>
<option value="Latvia">Latvia</option>
<option value="Lebanon">Lebanon</option>
<option value="Liechtenstein">Liechtenstein</option>
<option value="Lithuania">Lithuania</option>
<option value="Luxemburg">Luxemburg</option>
<option value="Macao">Macao</option>
<option value="Macedonia, Republic of">Macedonia, Republic of</option>
<option value="Malta">Malta</option>
<option value="Malaysia">Malaysia</option>
<option value="Marshall Islands">Marshall Islands</option>
<option value="Mexico">Mexico</option>
<option value="Morocco">Morocco</option>
<option value="Monaco">Monaco</option>
<option value="Moldova">Moldova</option>
<option value="Montenegro">Montenegro</option>
<option value="Myanmar">Myanmar</option>
<option value="Namibia">Namibia</option>
<option value="Netherlands">Netherlands</option>
<option value="New Zealand">New Zealand</option>
<option value="Norway">Norway</option>
<option value="Oman">Oman</option>
<option value="Pakistan">Pakistan</option>
<option value="Palestinian Territory">Palestinian Territory</option>
<option value="Panama">Panama</option>
<option value="Paraguay">Paraguay</option>
<option value="Peru">Peru</option>
<option value="Philippines">Philippines</option>
<option value="Poland">Poland</option>
<option value="Portugal">Portugal</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Qatar">Qatar</option>
<option value="Romania">Romania</option>
<option value="Serbia">Serbia</option>
<option value="Russian Federation">Russian Federation</option>
<option value="Saudi Arabia">Saudi Arabia</option>
<option value="Singapore">Singapore</option>
<option value="Slovenia">Slovenia</option>
<option value="Slovakia">Slovakia</option>
<option value="South Africa">South Africa</option>
<option value="Sri Lanka">Sri Lanka</option>
<option value="Sudan">Sudan</option>
<option value="Sweden">Sweden</option>
<option value="Switzerland">Switzerland</option>
<option value="Syrian Arab Republic (Syria)">Syrian Arab Republic (Syria)</option>
<option value="Taiwan, Republic of China">Taiwan, Republic of China</option>
<option value="Thailand">Thailand</option>
<option value="Tunisia">Tunisia</option>
<option value="Turkey">Turkey</option>
<option value="Ukraine">Ukraine</option>
<option value="United Arab Emirates">United Arab Emirates</option>
<option value="United Kingdom">United Kingdom</option>
<option value="United States">United States</option>
<option value="Uruguay">Uruguay</option>
<option value="Venezuela (Bolivarian Republic)">Venezuela (Bolivarian Republic)</option>
<option value="Vietnam">Vietnam</option>
</select></span></p>
<div data-id="countiesgroup" data-orig_data_id="countiesgroup" data-class="wpcf7cf_group" style="height: auto;" class="wpcf7cf-hidden">
<p>Select your state: </p>
<p>
<span class="wpcf7-form-control-wrap" data-name="state"><select name="state" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">---</option>
<option value="Alabama">Alabama</option>
<option value="Alaska">Alaska</option>
<option value="Arizona">Arizona</option>
<option value="Arkansas">Arkansas</option>
<option value="California">California</option>
<option value="Colorado">Colorado</option>
<option value="Connecticut">Connecticut</option>
<option value="Delaware">Delaware</option>
<option value="District of Columbia">District of Columbia</option>
<option value="Florida">Florida</option>
<option value="Georgia">Georgia</option>
<option value="Hawaii">Hawaii</option>
<option value="Idaho">Idaho</option>
<option value="Illinois">Illinois</option>
<option value="Indiana">Indiana</option>
<option value="Iowa">Iowa</option>
<option value="Kansas">Kansas</option>
<option value="Kentucky">Kentucky</option>
<option value="Louisiana">Louisiana</option>
<option value="Maine">Maine</option>
<option value="Maryland">Maryland</option>
<option value="Massachusetts">Massachusetts</option>
<option value="Michigan">Michigan</option>
<option value="Minnesota">Minnesota</option>
<option value="Mississippi">Mississippi</option>
<option value="Missouri">Missouri</option>
<option value="Montana">Montana</option>
<option value="Nebraska">Nebraska</option>
<option value="Nevada">Nevada</option>
<option value="New Hampshire">New Hampshire</option>
<option value="New Jersey">New Jersey</option>
<option value="New Mexico">New Mexico</option>
<option value="New York">New York</option>
<option value="North Carolina">North Carolina</option>
<option value="North Dakota">North Dakota</option>
<option value="Ohio">Ohio</option>
<option value="Oklahoma">Oklahoma</option>
<option value="Oregon">Oregon</option>
<option value="Pennsylvania">Pennsylvania</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Rhode Island">Rhode Island</option>
<option value="South Carolina">South Carolina</option>
<option value="South Dakota">South Dakota</option>
<option value="Tennessee">Tennessee</option>
<option value="Texas">Texas</option>
<option value="Utah">Utah</option>
<option value="Vermont">Vermont</option>
<option value="Virginia">Virginia</option>
<option value="Washington">Washington</option>
<option value="West Virginia">West Virginia</option>
<option value="Wisconsin">Wisconsin</option>
<option value="Wyoming">Wyoming</option>
</select></span>
</p>
</div>
<p style="margin-bottom: 10px;font-size: 11px;"><span class="wpcf7-form-control-wrap" data-name="gdpr-consent"><span class="wpcf7-form-control wpcf7-acceptance"><span class="wpcf7-list-item"><label><input type="checkbox" name="gdpr-consent"
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<p><span id="wpcf7-62f10def6a88e-wrapper" class="wpcf7-form-control-wrap county-wrap"><label for="wpcf7-62f10def6a88e-field" class="hp-message">Please leave this field empty.</label><input id="wpcf7-62f10def6a88e-field"
class="wpcf7-form-control wpcf7-text" type="text" name="county" value="" size="40" tabindex="0" autocomplete="new-password"></span></p>
<span class="wpcf7-form-control-wrap recaptcha"><span data-sitekey="6Ld5IU0UAAAAACrCkbMzml_RNn203llY5LCRm-cW" class="wpcf7-form-control g-recaptcha wpcf7-recaptcha">
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</form>
POST /integrated-product-development/#wpcf7-f8642-o2
<form action="/integrated-product-development/#wpcf7-f8642-o2" method="post" class="wpcf7-form init wpcf7-acceptance-as-validation" novalidate="novalidate" data-status="init">
<div style="display: none;">
<input type="hidden" name="_wpcf7" value="8642">
<input type="hidden" name="_wpcf7_version" value="5.6.1">
<input type="hidden" name="_wpcf7_locale" value="de_DE">
<input type="hidden" name="_wpcf7_unit_tag" value="wpcf7-f8642-o2">
<input type="hidden" name="_wpcf7_container_post" value="0">
<input type="hidden" name="_wpcf7_posted_data_hash" value="">
<input type="hidden" name="_wpcf7cf_hidden_group_fields" value="["state"]">
<input type="hidden" name="_wpcf7cf_hidden_groups" value="["countiesgroup"]">
<input type="hidden" name="_wpcf7cf_visible_groups" value="[]">
<input type="hidden" name="_wpcf7cf_repeaters" value="[]">
<input type="hidden" name="_wpcf7cf_steps" value="{}">
<input type="hidden" name="_wpcf7cf_options"
value="{"form_id":8642,"conditions":[{"then_field":"countiesgroup","and_rules":[{"if_field":"country","operator":"equals","if_value":"United States"}]}],"settings":{"animation":"yes","animation_intime":200,"animation_outtime":200,"conditions_ui":"normal","notice_dismissed":false,"notice_dismissed_rollback-cf7-5.5.1":true}}">
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</div>
<div class="wpcf7-response-output" aria-hidden="true"></div>
<p><span class="wpcf7-form-control-wrap" data-name="first-name"><input type="text" name="first-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="Your First Name (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="last-name"><input type="text" name="last-name" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-validates-as-required input_field" id="your-name" aria-required="true"
aria-invalid="false" placeholder="Your Last Name (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="e-mail"><input type="email" name="e-mail" value="" size="40" class="wpcf7-form-control wpcf7-text wpcf7-email wpcf7-validates-as-required wpcf7-validates-as-email input_field" id="email"
aria-required="true" aria-invalid="false" placeholder="Your Email (Mandatory)"></span><br>
<span class="wpcf7-form-control-wrap" data-name="phone"><input type="text" name="phone" value="" size="40" class="wpcf7-form-control wpcf7-text input_field" id="your-name" aria-invalid="false" placeholder="Your Telephone Number"></span><br>
<span class="wpcf7-form-control-wrap" data-name="question"><textarea name="question" cols="40" rows="4" class="wpcf7-form-control wpcf7-textarea wpcf7-validates-as-required input_field" id="question" aria-required="true" aria-invalid="false"
placeholder="Your question (Mandatory)"></textarea></span>
</p>
<p><span class="wpcf7-form-control-wrap" data-name="country"><select name="country" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">Where are you located?</option>
<option value="Afghanistan">Afghanistan</option>
<option value="Albania">Albania</option>
<option value="Algeria">Algeria</option>
<option value="Armenia">Armenia</option>
<option value="Argentina">Argentina</option>
<option value="Austria">Austria</option>
<option value="Australia">Australia</option>
<option value="Azerbaijan">Azerbaijan</option>
<option value="Bangladesh">Bangladesh</option>
<option value="Belarus">Belarus</option>
<option value="Belgium">Belgium</option>
<option value="Bosnia and Herzegovina">Bosnia and Herzegovina</option>
<option value="Bolivia">Bolivia</option>
<option value="Brazil">Brazil</option>
<option value="British Virgin Islands">British Virgin Islands</option>
<option value="Bulgaria">Bulgaria</option>
<option value="Canada">Canada</option>
<option value="Chile">Chile</option>
<option value="China">China</option>
<option value="Colombia">Colombia</option>
<option value="Costa Rica">Costa Rica</option>
<option value="Croatia">Croatia</option>
<option value="Cuba">Cuba</option>
<option value="Cyprus">Cyprus</option>
<option value="Czech Republic">Czech Republic</option>
<option value="Denmark">Denmark</option>
<option value="Dominican Republic">Dominican Republic</option>
<option value="Ecuador">Ecuador</option>
<option value="El Salvador">El Salvador</option>
<option value="Estonia">Estonia</option>
<option value="Egypt">Egypt</option>
<option value="Spain">Spain</option>
<option value="Finland">Finland</option>
<option value="France">France</option>
<option value="Georgia">Georgia</option>
<option value="Germany">Germany</option>
<option value="Ghana">Ghana</option>
<option value="Greece">Greece</option>
<option value="Honduras">Honduras</option>
<option value="Hungary">Hungary</option>
<option value="Iceland">Iceland</option>
<option value="India">India</option>
<option value="Indonesia">Indonesia</option>
<option value="Israel">Israel</option>
<option value="Ireland">Ireland</option>
<option value="Iraq">Iraq</option>
<option value="Iran, Islamic Republic of">Iran, Islamic Republic of</option>
<option value="Isle of Man">Isle of Man</option>
<option value="Italy">Italy</option>
<option value="Jamaica">Jamaica</option>
<option value="Japan">Japan</option>
<option value="Jordan">Jordan</option>
<option value="Kazakhstan">Kazakhstan</option>
<option value="Korea (North)">Korea (North)</option>
<option value="Korea (South)">Korea (South)</option>
<option value="Kuwait">Kuwait</option>
<option value="Latvia">Latvia</option>
<option value="Lebanon">Lebanon</option>
<option value="Liechtenstein">Liechtenstein</option>
<option value="Lithuania">Lithuania</option>
<option value="Luxemburg">Luxemburg</option>
<option value="Macao">Macao</option>
<option value="Macedonia, Republic of">Macedonia, Republic of</option>
<option value="Malta">Malta</option>
<option value="Malaysia">Malaysia</option>
<option value="Marshall Islands">Marshall Islands</option>
<option value="Mexico">Mexico</option>
<option value="Morocco">Morocco</option>
<option value="Monaco">Monaco</option>
<option value="Moldova">Moldova</option>
<option value="Montenegro">Montenegro</option>
<option value="Myanmar">Myanmar</option>
<option value="Namibia">Namibia</option>
<option value="Netherlands">Netherlands</option>
<option value="New Zealand">New Zealand</option>
<option value="Norway">Norway</option>
<option value="Oman">Oman</option>
<option value="Pakistan">Pakistan</option>
<option value="Palestinian Territory">Palestinian Territory</option>
<option value="Panama">Panama</option>
<option value="Paraguay">Paraguay</option>
<option value="Peru">Peru</option>
<option value="Philippines">Philippines</option>
<option value="Poland">Poland</option>
<option value="Portugal">Portugal</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Qatar">Qatar</option>
<option value="Romania">Romania</option>
<option value="Serbia">Serbia</option>
<option value="Russian Federation">Russian Federation</option>
<option value="Saudi Arabia">Saudi Arabia</option>
<option value="Singapore">Singapore</option>
<option value="Slovenia">Slovenia</option>
<option value="Slovakia">Slovakia</option>
<option value="South Africa">South Africa</option>
<option value="Sri Lanka">Sri Lanka</option>
<option value="Sudan">Sudan</option>
<option value="Sweden">Sweden</option>
<option value="Switzerland">Switzerland</option>
<option value="Syrian Arab Republic (Syria)">Syrian Arab Republic (Syria)</option>
<option value="Taiwan, Republic of China">Taiwan, Republic of China</option>
<option value="Thailand">Thailand</option>
<option value="Tunisia">Tunisia</option>
<option value="Turkey">Turkey</option>
<option value="Ukraine">Ukraine</option>
<option value="United Arab Emirates">United Arab Emirates</option>
<option value="United Kingdom">United Kingdom</option>
<option value="United States">United States</option>
<option value="Uruguay">Uruguay</option>
<option value="Venezuela (Bolivarian Republic)">Venezuela (Bolivarian Republic)</option>
<option value="Vietnam">Vietnam</option>
</select></span></p>
<div data-id="countiesgroup" data-orig_data_id="countiesgroup" data-class="wpcf7cf_group" style="height: auto;" class="wpcf7cf-hidden">
<p>Select your state: </p>
<p>
<span class="wpcf7-form-control-wrap" data-name="state"><select name="state" class="wpcf7-form-control wpcf7-select wpcf7-validates-as-required" aria-required="true" aria-invalid="false">
<option value="">---</option>
<option value="Alabama">Alabama</option>
<option value="Alaska">Alaska</option>
<option value="Arizona">Arizona</option>
<option value="Arkansas">Arkansas</option>
<option value="California">California</option>
<option value="Colorado">Colorado</option>
<option value="Connecticut">Connecticut</option>
<option value="Delaware">Delaware</option>
<option value="District of Columbia">District of Columbia</option>
<option value="Florida">Florida</option>
<option value="Georgia">Georgia</option>
<option value="Hawaii">Hawaii</option>
<option value="Idaho">Idaho</option>
<option value="Illinois">Illinois</option>
<option value="Indiana">Indiana</option>
<option value="Iowa">Iowa</option>
<option value="Kansas">Kansas</option>
<option value="Kentucky">Kentucky</option>
<option value="Louisiana">Louisiana</option>
<option value="Maine">Maine</option>
<option value="Maryland">Maryland</option>
<option value="Massachusetts">Massachusetts</option>
<option value="Michigan">Michigan</option>
<option value="Minnesota">Minnesota</option>
<option value="Mississippi">Mississippi</option>
<option value="Missouri">Missouri</option>
<option value="Montana">Montana</option>
<option value="Nebraska">Nebraska</option>
<option value="Nevada">Nevada</option>
<option value="New Hampshire">New Hampshire</option>
<option value="New Jersey">New Jersey</option>
<option value="New Mexico">New Mexico</option>
<option value="New York">New York</option>
<option value="North Carolina">North Carolina</option>
<option value="North Dakota">North Dakota</option>
<option value="Ohio">Ohio</option>
<option value="Oklahoma">Oklahoma</option>
<option value="Oregon">Oregon</option>
<option value="Pennsylvania">Pennsylvania</option>
<option value="Puerto Rico">Puerto Rico</option>
<option value="Rhode Island">Rhode Island</option>
<option value="South Carolina">South Carolina</option>
<option value="South Dakota">South Dakota</option>
<option value="Tennessee">Tennessee</option>
<option value="Texas">Texas</option>
<option value="Utah">Utah</option>
<option value="Vermont">Vermont</option>
<option value="Virginia">Virginia</option>
<option value="Washington">Washington</option>
<option value="West Virginia">West Virginia</option>
<option value="Wisconsin">Wisconsin</option>
<option value="Wyoming">Wyoming</option>
</select></span>
</p>
</div>
<p style="margin-bottom: 10px;font-size: 11px;"><span class="wpcf7-form-control-wrap" data-name="gdpr-consent"><span class="wpcf7-form-control wpcf7-acceptance"><span class="wpcf7-list-item"><label><input type="checkbox" name="gdpr-consent"
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<span class="wpcf7-form-control-wrap recaptcha"><span data-sitekey="6Ld5IU0UAAAAACrCkbMzml_RNn203llY5LCRm-cW" class="wpcf7-form-control g-recaptcha wpcf7-recaptcha">
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Accept All CookiesCookie PreferencesCookie Control Close Icon ,,,,,,,,,,,,,,,,,,,,,,,,,,,, * Biopharma Excellence * News & Events * Industry News Articles * Press Releases * Webinars * Events * Blog * Podcasts * Resource Library * Thought Leadership * Fact Flyers * Case Studies * White Papers * Webinars * Infographics * Video & Animation * Careers * Life at PharmaLex * Current Opportunities * Training ———Biopharma ExcellenceNews & Events— Industry News Articles— Press Releases— Webinars— Events— Blog— PodcastsResource Library— Thought Leadership— Fact Flyers— Case Studies— White Papers— Webinars— Infographics— Video & AnimationCareers— Life at PharmaLex— Current OpportunitiesTraining———Top Bar Search MENUMENU * * * About UsAbout Us * About Us * Management Team * Corporate Social Responsibility * What Our Clients Say About Us * Our Services * Discovery / Non-clinical * * * Go to Discovery / Non-clinical section >> * * * STRATEGY AND CONSULTING * Integrated Product Development * Market Access * Scientific Advice * Statistics and Data Sciences * Toxicology Services * Clinical Development * * * Go to Clinical Development section >> * * * STRATEGY AND CONSULTING * Clinical Program Development * Scientific Advice * Statistics and Data Sciences * REGULATORY AFFAIRS * Clinical Trial Applications * Global Procedure Management * Health Authority / Agency Interaction * Regulatory Operations * * PHARMACOVIGILANCE * Clinical Trial Safety Support * Pharmacovigilance Consulting * QUALITY * GxP Services * Interim / Contract QA * Quality Management Systems * Tech Transfer / Scale-up * Authorization / Approval * * * Go to Authorization / Approval section >> * * * STRATEGY AND CONSULTING * Market Access * REGULATORY AFFAIRS * CMC Services * Global Procedure Management * Health Authority / Agency Interaction * Marketing and Labeling Activities * Regulatory Operations * Scientific, Regulatory and Technical Writing * Statistics and Data Sciences * * PHARMACOVIGILANCE * EU QPPV / National QPPV * Pharmacovigilance Consulting * QUALITY * Commercialization Readiness * Commissioning, Qualification, and Validation (CQV) * GxP Services * Interim / Contract QA * PAI Readiness * Post-approval / Maintenance * * * Go to Post-approval / Maintenance section >> * * * STRATEGY AND CONSULTING * Market Access * REGULATORY AFFAIRS * CMC Services * Global End-to-End Outsourcing * Global Procedure Management * Health Authority / Agency Interaction * Marketing and Labeling Activities * Mergers and Acquisitions (M&A) Transfers * Regulatory Operations * Toxicology Services * PHARMACOVIGILANCE * EU QPPV / National QPPV * ICSR (Individual Safety Case Report) Management * Literature Monitoring & Screening * Pharmacovigilance Quality & Compliance * Signal Management * * QUALITY * Commissioning, Qualification, and Validation (CQV) * GxP Services * Interim / Contract QA * Quality Management Systems * MEDICAL AFFAIRS * Healthcare Compliance and Medical Approval * Program Management * * * Go to Program Management section >> * PROGRAM MANAGEMENT * Global End-to-End Outsourcing * Global Procedure Management * Integrated Product Development * Mergers and Acquisitions (M&A) Transfers * Featured Expertise * * * INDUSTRY EXPERTISE * Biopharmaceuticals * MedTech Services * * SERVICE EXPERTISE * ATMP / Cell and Gene Therapy * COVID-19 Support * GxP Services * Market Access * Pharmacovigilance Consulting * Post-Brexit Regulatory Support * Statistics and Data Sciences * * SMARTPHLEX - technology-enabled services * Global ReachGlobal Reach * Contact usContact us * News & Events * Industry News Articles * Press Releases * Webinars * Events * Blog * Podcasts * Resource Library * Thought Leadership * Fact Flyers * Case Studies * White Papers * Webinars * Infographics * Video & Animation * Careers * Life at PharmaLex * Career Opportunities * Training * INTEGRATED PRODUCT DEVELOPMENT Services Resources Contact A HOLISTIC AND STRATEGIC ASSET MANAGEMENT PARTNERSHIP Introducing a new drug to market requires a complex interplay of multiple activities and disciplines. For a successful launch, drug developers need a partner that offers holistic solutions and collaborative expertise to help them overcome rising R&D costs and growing regulatory complexities. That’s where a foresighted approach, such as Integrated Product Development (IPD), can make the difference. Going far beyond basic project management, the Integrated Product Development program at PharmaLex represents a partnership between you and our team. Our experts actively contribute to your product’s path to success by integrating nonclinical/clinical, toxicological and crucial biostatistical support with Chemistry, Manufacturing and Controls (CMC) services, regulatory strategy, quality management and compliance support and a well-planned market access approach. A BENCH TO BEDSIDE APPROACH Our Integrated Product Development team delivers holistic support from discovery through to development, preparing everything for a smooth transition to product launch, including clinical and medical writing and guidance and support during critical agency interactions. We understand the importance of integrated collaboration among different functions and stakeholders from the outset. Rather than following a linear approach that addresses the process phase by phase, we integrate the various functional activities of key departments to save you time, reduce risk, lower costs and, ultimately, drive commercial success. TALK TO AN EXPERT VIEW ALL RESOURCES A TARGET PRODUCT PROFILE Your development strategy must include a clear, well-defined destination—typically a target product profile—that states where your drug fits into clinical practice and the global marketplace. Our Integrated Product Development team helps identify and sharpen your target product profile early in the development process to guide the design of an integrated development plan that includes a regulatory/clinical roadmap, strategy and mitigation plan. EXPERT TEAMWORK Integrated Product Development is based on a highly collaborative, multidisciplinary approach. Our Integrated Product Development teams work closely with subject matter experts on a variety of topics including: SERVICES AT A GLANCE SCIENTIFIC ADVICE GETTING THE BEST OUT OF SCIENTIFIC ADVICE FROM HEALTH AUTHORITIES Having provided Scientific Advice for more than 150 clients over the last five years, PharmaLex has considerable experience in leading clients through the process, with FDA in the US, the EMA in the EU and other major Health Authorities in- and outside of the EU. LEARN MORE CHEMISTRY, MANUFACTURING AND CONTROLS (CMC) CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. LEARN MORE TECH TRANSFER / SCALE-UP Pharmaceutical batch sizes manufactured to support the NDA or ANDA license application are typically scaled up after approval. FDA Scale-up and Post Approval Changes (SUPAC) guidance provides recommendations to product license holders on scale-up of the process and making a change to the site of manufacture or testing post NDA or ANDA approval. Scale-up activities should be managed under the Pharmaceutical Quality System (ICH Q10). LEARN MORE STATISTICS AND DATA SCIENCE THE BENEFITS AND BEST PRACTICES OF DATA ANALYTICS The Global Statistics and Data Science (GSDS) team at PharmaLex delivers analytical support for the development of medical products from early research through pre-clinical to late phase studies, plus manufacturing and health economics. LEARN MORE TOXICOLOGY SERVICES Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data into the right context of patient exposure (dose) it informs whether patient safety is unlikely to be compromised and therefore the likelihood of regulatory acceptance. This is the foundation of toxicological risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualifications and experience. PharmaLex has an experienced team of toxicologists to guide you through a risk assessment. LEARN MORE CLINICAL PROGRAM DEVELOPMENT PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first-in-man studies through registration studies as well as post-approval programs. LEARN MORE CLINICAL TRIAL APPLICATIONS With clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side. PharmaLex provides support for all aspects of Clinical Trial Authorization (CTA) and Investigational New Drug (IND) applications. LEARN MORE HEALTH AUTHORITY / AGENCY INTERACTION ENSURING REGULATORY SUCCESS Meetings with Health Authorities such as the FDA in the US, the EMA in Europe and other major regulatory bodies worldwide have shown to increase the probability of market approval and can favorably impact on development times and costs. Since Health Authorities make the final decision to approve or reject products, it is highly recommended to optimize authority communication through face-to-face and teleconference meetings all along the development pathway. But how do you get the best out of your meeting with a Health Authority? LEARN MORE REGULATORY OPERATIONS Modern Regulatory Operations is about proactively implementing efficient information management, scalable operational excellence, and innovative digital solutions like regulatory automation. For over 15 years, we have led the way in regulatory submissions with an evolving holistic approach that includes everything from planning to embedded quality control. Of course, all of our services are complemented by state-of-the-art digital facilitation. LEARN MORE QUALITY MANAGEMENT SYSTEMS The Quality Management System (QMS) is the backbone of every life sciences organization. It is the formalized system that documents procedures, processes and responsibilities for achieving regulatory and quality policies and objectives. A well designed, tailored and implemented QMS should enable and facilitate your organization to effectively and efficiently progress through R&D, Clinical and Commercial operations. A one-size-fits-all approach is neither practical nor preferable. Instead, the QMS should be phase-appropriate. It should be fitted and adapted to the organization’s development stage – whether you’re in early clinical, late clinical or commercial – and to your business model, for example: in-house manufacture versus virtual or contract manufacture. LEARN MORE GXP SERVICES Ensuring your internal systems, or those of your supplier or client, meet the necessary requirements is essential before undertaking any regulatory process. It is also pertinent to follow good practice (GxP) guidelines in order to satisfy the regulators that all aspects meet their standards. LEARN MORE MARKET ACCESS STRATEGY The key to unlocking market access, is the ability to look beyond the science, to understand the market dynamics that will shape the future and drive value To gain market access in pharma and remain competitive, pharmaceutical and medical technology manufacturers must be able to demonstrate clinical and economic evidence to providers, healthcare decision-makers and payers. LEARN MORE YOUR INTEGRATED PRODUCT DEVELOPMENT LEAD At PharmaLex, clients work with a dedicated Integrated Product Development lead who acts as both a strategic lead and project manager. It is their responsibility to make sure your IPD program stays on track. Each one of our Integrated Product Development leads is a member of our Global Center for Integrated Development—a network of senior consultants from various PharmaLex service areas with extensive drug development experience. AVAILABLE RESOURCES WEBINARS * Bench to Bedside: The need for an Integrated Product Strategy * Medical Device Risk Management for Patient and Product Safety * Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution * Marketing a drug in France, what are the responsibilities of an exploitant? * Introduction to Bayesian Methodologies in CMC * Biotech Drug Development Challenges and Case Studies (CMC) * Overview of the biotech drug development pathway * Achieving and maintaining REG CMC Compliance * Regulatory Landscape for Tissue, Cell and Gene Therapy * Optimize your biosimilar development strategy * What you need to know to submit INDs in eCTD format RELATED ARTICLES Integrated Product Development for new osteoarthritis treatments 5th August 2022 Why collaboration and an Integrated Product Development program are key to successful drug development 14th June 2022 Proven Approaches to Accelerate Pharma Drug Development 16th November 2021 MORE RESOURCES THOUGHT LEADERSHIP * IPI publication: Non-clinical safety evaluation of vaccines accelerating clinical development * Chemistry Today publication: Non-clinical safety evaluation of vaccines accelerating clinical development * Teknoscience publication: Successful marketing of medicinal cannabis * Successful marketing of medicinal cannabis part II * Non-clinical safety evaluation of vaccines part II * Non-clinical safety evaluation of vaccines part I * Can a robust QMS help you achieve customer satisfaction? * Product Launch * Learning Lessons from Nitrosamine Impurities * Drug Development Decisions * The FDA is shifting focus to both ends of the NPD spectrum * Improving Availability of Medicines in the EU * EMA simplifies the process for internal transfer of MAs FACT FLYERS * Strategic Regulatory Operations * FDA meetings and health authority interactions * Veeva Vault RIM Implementation * ATMP Quick Links and Guidelines * Advanced Therapies - Navigating through the Regulatory Framework * Regulatory Compliance - CMC Implementation * Biopharmaceuticals CMC * Health Authority Interactions * Chemistry, Manufacturing and Control (CMC) CASE STUDIES * System suitability control limits for assay with format * PharmaLex expertise secures CE certification for medical devices ‘at risk’ * PharmaLex delivers huge sales upturn with regulatory strategy * MA applications to EMA and FDA in parallel * Dendritic cell vaccine (oncology) * Regulatory CMC Compliance reduced risk * Pre-IND Meeting * Type C Meeting * End of Phase-2 meeting * RIM-DMS Data Clean-up * Veeva Vault RIM Implementation * Consultancy and eCTD submission support for master files * Portfolio Maintenance Outsourcing – Global RA responsibility * Strategic outsourcing of mature product portfolio * Global CMC responsibility during portfolio integration * Post–M&A pharma infrastructure development * M&A early strategy * Lifecycle management for drug products * Regulatory CMC compliance reduced workload by 20-25% * Flexible eCTD publishing support * Due diligence for medicinal product documentation * US-UK Phase II clinical trial support * Preparation, submission and coordination of a CP for PUMA * ERA for an active substance in antiseptic lozenges WHITE PAPERS * Solving the Life Sciences Innovation Dilemma with an Integrated Product Development Strategy * Pharma's growing interest in probiotics - a challenge or an opportunity? * The medical device regulations and their implications on device vigilance * New responsibilities for importers * Successful marketing of medicinal cannabis and cannabis-derived products - Part II * Successful marketing of medicinal cannabis and cannabis-derived products * Together Beyond COVID-19 - A Look at the Future * The Challenges of Achieving and Maintaining CMC Compliance * Analysis of EMA's Product Management Services * Nitrosamines - information for MAHs * Pre-IND meetings | The opportunity for early FDA feedback * Differing CMC requirements: US and EU WEBINARS * Bench to Bedside: The need for an Integrated Product Strategy * Medical Device Risk Management for Patient and Product Safety * Excipient Risk Assessment as per the EU Guidance and SMARTRISK as a solution * Marketing a drug in France, what are the responsibilities of an exploitant? * Introduction to Bayesian Methodologies in CMC * Biotech Drug Development Challenges and Case Studies (CMC) * Overview of the biotech drug development pathway * Achieving and maintaining REG CMC Compliance * Regulatory Landscape for Tissue, Cell and Gene Therapy * Optimize your biosimilar development strategy * What you need to know to submit INDs in eCTD format INFOGRAPHICS * INTEGRATED PRODUCT DEVELOPMENT - QUICK REFERENCE GUIDE * Biosimilar Development GLOBAL REACH. 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