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Submission: On July 27 via api from US — Scanned from GB
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*
* About Us
* * * About UsWe are leading provider of specialized services for the
pharmaceutical, biotech and medical device industries, compliance is
our priority.
* SustainabilityWe are focusing our efforts on initiatives that revolve
around education, empowerment and inclusivity and sustainability.
* * Management TeamOur management team is committed to create a friendly
working environment, provide confidence to our customers and support a
environmental-friendly company.
* Our LocationsWe service our clients through our regional hubs that
collaborate on projects at global, regional and local levels
* * Corporate Social ResponsibilityHaving the ability to invest in
sustainable environmental and social wellbeing is an important part of
our attitude to business as well as helping to reinforce our values.
* TrainingEnhancing our industry by delivering high-quality specialist
training courses.
* Solutions
* * * Industry Solutions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
Industry Sectors
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
Departments
Services
Research and Development
Statistics and Data Science
Market Access
Patient Safety (Pharmacovigilance)
Regulatory Affairs and CMC
Quality Management and Compliance
Training
Research and Development
* Clinical Development Services
* Clinical Trial Applications
* Development Strategy
* Toxicological Services and Risk Assessment
Statistics and Data Science
* Clinical Biostatistics
* CMC Statistics
* Discovery Statistics
* Omics Data Science
Market Access
* Health economics and outcomes research (HEOR)
* Market Access Strategy
* Pricing and Reimbursement
Patient Safety (Pharmacovigilance)
* Clinical Trials Adverse Event Processing
* Gap Analysis and Consulting
* ICSR Management
* Literature Surveillance
* Monitoring and Signal Detection
* Pharmacovigilance Audits
* Qualified Person for Pharmacovigilance (QPPV)
Regulatory Affairs and CMC
* Agency Interactions
* CMC Biologics
* CMC Services
* eCTD, System Operations and Data Management
* Post-Approval Maintenance
* Promotional Materials & Compliance
* Regulatory Writing / Scientific and Technical Writing
Quality Management and Compliance
* Commissioning, Qualification and Validation
* Computer System Validation (CSV)
* GxP Audit
* GxP Technical Consulting
* Quality Systems and Compliance
Enhancing our industry by delivering high-quality specialist training
courses.
* Solutions
* Industry Solutions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Local Affiliate Services
* Business and Portfolio Mergers & Acquisitions
* Sectors
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
* Departments
* Research and Development
* Statistics and Data Science
* Market Access
* Patient Safety (Pharmacovigilance)
* Regulatory Affairs and CMC
* Quality Management and Compliance
* Insights
* * * News & Events
* Webinars
* Events
* Company News
* * Thought Leadership
* White Papers
* Infographics
* Blog & Articles
* Videos
* Journal Articles
* Podcasts
* * Rebuttal: eCTD 4.0: More, Sooner!
Blog & Article
* 26th July 2024
Are you confident in your combination product requirements?
Infographic
Key Steps for Site Inspection Readiness
Podcast
* 17th July 2024
* 17m
Alleviating the Regulatory Burden Through the Access Consortium
Journal Article
* 11th July 2024
* Insights
* News & Events
* Webinars
* Events
* Company News
* Thought Leadership
* White Papers
* Infographics
* Blog & Articles
* Videos
* Journal Articles
* Podcasts
* Digital Innovation
* Careers
* * * CareersWe are dedicated to creating a sustainable work-life balance to
support our highly motivated team in this fun and challenging
environment.
* Your Application ProcessWe want to give you some tips for the
application process.
* * Life at PharmaLexWe are proud of what our employees say about us. Read
their testimonials.
* * Current OpportunitiesWe prefer online applications – it’s very easy and
is the fastest way to success for you and us. You can easily upload
your attachments, such as your CV and cover letter, in all common
formats.
* Contact Us
*
* Global Reach
*
*
* About Us
* * * About UsWe are leading provider of specialized services for the
pharmaceutical, biotech and medical device industries, compliance is
our priority.
* SustainabilityWe are focusing our efforts on initiatives that revolve
around education, empowerment and inclusivity and sustainability.
* * Management TeamOur management team is committed to create a friendly
working environment, provide confidence to our customers and support a
environmental-friendly company.
* Our LocationsWe service our clients through our regional hubs that
collaborate on projects at global, regional and local levels
* * Corporate Social ResponsibilityHaving the ability to invest in
sustainable environmental and social wellbeing is an important part of
our attitude to business as well as helping to reinforce our values.
* TrainingEnhancing our industry by delivering high-quality specialist
training courses.
* Solutions
* * * Industry Solutions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
Industry Sectors
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
Departments
Services
Research and Development
Statistics and Data Science
Market Access
Patient Safety (Pharmacovigilance)
Regulatory Affairs and CMC
Quality Management and Compliance
Training
Research and Development
* Clinical Development Services
* Clinical Trial Applications
* Development Strategy
* Toxicological Services and Risk Assessment
Statistics and Data Science
* Clinical Biostatistics
* CMC Statistics
* Discovery Statistics
* Omics Data Science
Market Access
* Health economics and outcomes research (HEOR)
* Market Access Strategy
* Pricing and Reimbursement
Patient Safety (Pharmacovigilance)
* Clinical Trials Adverse Event Processing
* Gap Analysis and Consulting
* ICSR Management
* Literature Surveillance
* Monitoring and Signal Detection
* Pharmacovigilance Audits
* Qualified Person for Pharmacovigilance (QPPV)
Regulatory Affairs and CMC
* Agency Interactions
* CMC Biologics
* CMC Services
* eCTD, System Operations and Data Management
* Post-Approval Maintenance
* Promotional Materials & Compliance
* Regulatory Writing / Scientific and Technical Writing
Quality Management and Compliance
* Commissioning, Qualification and Validation
* Computer System Validation (CSV)
* GxP Audit
* GxP Technical Consulting
* Quality Systems and Compliance
Enhancing our industry by delivering high-quality specialist training
courses.
* Solutions
* Industry Solutions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Local Affiliate Services
* Business and Portfolio Mergers & Acquisitions
* Sectors
* Biotech
* Pharmaceutical & Consumer Health
* MedTech
* Departments
* Research and Development
* Statistics and Data Science
* Market Access
* Patient Safety (Pharmacovigilance)
* Regulatory Affairs and CMC
* Quality Management and Compliance
* Insights
* * * News & Events
* Webinars
* Events
* Company News
* * Thought Leadership
* White Papers
* Infographics
* Blog & Articles
* Videos
* Journal Articles
* Podcasts
* * Rebuttal: eCTD 4.0: More, Sooner!
Blog & Article
* 26th July 2024
Are you confident in your combination product requirements?
Infographic
Key Steps for Site Inspection Readiness
Podcast
* 17th July 2024
* 17m
Alleviating the Regulatory Burden Through the Access Consortium
Journal Article
* 11th July 2024
* Insights
* News & Events
* Webinars
* Events
* Company News
* Thought Leadership
* White Papers
* Infographics
* Blog & Articles
* Videos
* Journal Articles
* Podcasts
* Digital Innovation
* Careers
* * * CareersWe are dedicated to creating a sustainable work-life balance to
support our highly motivated team in this fun and challenging
environment.
* Your Application ProcessWe want to give you some tips for the
application process.
* * Life at PharmaLexWe are proud of what our employees say about us. Read
their testimonials.
* * Current OpportunitiesWe prefer online applications – it’s very easy and
is the fastest way to success for you and us. You can easily upload
your attachments, such as your CV and cover letter, in all common
formats.
* Contact Us
*
* Global Reach
*
GLOBAL SOLUTIONS WHEREVER YOU ARE IN YOUR PRODUCT'S LIFECYCLE
Biotech
Pharmaceutical
Medtech
Business and portfolio mergers and acquisitions
Bringing innovations to market
Integrated product development
Strategic and scientific consultancy
Optimal patient access
From pipeline to patient, we invite you to join us as we aim to elevate your
understanding of key industry challenges and help you reach new heights of
success.
LATEST INSIGHTS
As Pharma consultants, we love to share our knowledge! Check out our blogs,
webinars, articles, podcasts and more. Connect with our experts and stay
up-to-date on all of the trends in the pharmaceutical, biotech and medical
device industries.
Webinar
SUMMER SHORTS: HOUSE OF THE INSPECTOR
* August 13th, 2024
Blog & Article
REBUTTAL: ECTD 4.0: MORE, SOONER!
* 26th July 2024
Journal Article
ALLEVIATING THE REGULATORY BURDEN THROUGH THE ACCESS CONSORTIUM
* July 11, 2024
Podcast
KEY STEPS FOR SITE INSPECTION READINESS
* July 17, 2024
* 17m
Company News
WE ARE NOW CENCORA PHARMALEX
* 30th January 2024
White Paper
20 YEARS OF BIOSIMILARS: ARE WE ON THE RIGHT TRACK?
* May 24, 2024
Webinar
SUMMER SHORTS: HOUSE OF THE INSPECTOR
* August 13th, 2024
Blog & Article
REBUTTAL: ECTD 4.0: MORE, SOONER!
* 26th July 2024
Journal Article
ALLEVIATING THE REGULATORY BURDEN THROUGH THE ACCESS CONSORTIUM
* July 11, 2024
Podcast
KEY STEPS FOR SITE INSPECTION READINESS
* July 17, 2024
* 17m
Company News
WE ARE NOW CENCORA PHARMALEX
* 30th January 2024
White Paper
20 YEARS OF BIOSIMILARS: ARE WE ON THE RIGHT TRACK?
* May 24, 2024
Webinar
SUMMER SHORTS: HOUSE OF THE INSPECTOR
* August 13th, 2024
Blog & Article
REBUTTAL: ECTD 4.0: MORE, SOONER!
* 26th July 2024
Previous
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View all Insights
FUNCTIONAL AREAS
REGULATORY AFFAIRS
Maneuver regulations with confidence — the stakes for your therapy are high
TMF
Bring order, stability, and control to your TMF — our people make it happen
PHARMACOVIGILANCE
Free your safety and clinical teams to focus on what matters most
QUALITY MANAGEMENT AND COMPLIANCE
Navigate compliance, master quality — from innovation to commercialization
SCIENTIFIC DEVELOPMENT CONSULTING
Turn potential into performance with proven strategies
MEDTECH REGULATORY
Turn your medtech innovations into real-world patient impact
CORPORATE SOCIAL RESPONSIBILITY
We are keenly focused on initiatives that revolve around education, empowerment,
inclusivity and sustainability.
More Information
PHARMALEX IN NUMBERS
Satisfaction
1 %
9 out of 10 top pharmaceutical companies are satisfied clients
Nationalities
1 +
Nationalities on staff, including former FDA and EMA experts
Net Promoter Score
1 %
High satisfaction scores from satisfied clients
SMES
1 %
Customers include high percentage of small-medium-sized enterprises
COMPANY
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* Corporate Social Responsibility
* Sustainability
* Management Team
* Sectors
* About Us
* Corporate Social Responsibility
* Sustainability
* Management Team
* Sectors
USEFUL LINKS
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* Imprint
* Data Protection
* Terms and Conditions
* UK Modern Slavery Act Statement
* Contact Us
* Imprint
* Data Protection
* Terms and Conditions
* UK Modern Slavery Act Statement
SOLUTIONS
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
* Strategic and Scientific Consultancy
* Integrated Product Development
* Innovations to Market
* Optimal Patient Access
* Business and Portfolio Mergers & Acquisitions
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