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* About ProPharma
About Us
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* RCO Solutions
RCO Solutions
Leading with strategy, our RCO model delivers bespoke / custom solutions that
deliver results. Our fit-for purpose global solutions span across the full
product lifecycle.
* Discovery and Development
* Technology Transformation
* Research Platforms
* Target & Lead Selection
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Leading with strategy, our RCO model delivers bespoke / custom solutions that
deliver results. Our fit-for purpose global solutions span across the full
product lifecycle.
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DE 日本語 EN
SOARING
BEYOND
CRO
Inspiring the future of science to
deliver the technologies, medicines
& therapies of tomorrow.
Speak with an Expert
PROPHARMA PROUDLY INTRODUCES SOMETHING NEW: THE RCO.
The traditional CRO model wasn’t built to handle today’s needs. As the first
ever Research Consulting Organization (RCO), we lead with strategy; this enables
customized design and delivery of consulting solutions that are equipped to
successfully navigate the increasingly complex global Regulatory environment.
Our scalable nature and agility allows each part of our business to invest,
innovate, and continuously improve to provide the right solutions for our
clients.
- Michael Stomberg, Chief Executive Officer
Explore Our RCO Model Download the Whitepaper
BETTER SOLUTIONS. INNOVATIVE PARTNERS.
WELCOME TO THE FUTURE OF RESEARCH CONSULTING.
We revolutionized the traditional model, creating an entirely new system that
redefines what’s possible for you and your organization. Meet the Research
Consulting Organization (RCO).
Explore Our RCO Solutions
BESPOKE SOLUTIONS
We lead with consulting to co-create the optimal solution for your needs. We
support our clients by harnessing our targeted SMEs to advise on strategy to
create the most efficient solution and continuously support the
product-lifecycle. We enable the bespoke operating model and related
capabilities and support development. Lastly, we execute the plan and scale the
model through the commercial and post-marketing phases.
DEEP DOMAIN EXPERTISE
Select from a comprehensive array of full product lifecycle services to create a
fit-for-purpose solution. These services by design, operate autonomously in a
model that can be engaged individually to help with a specific need or assembled
into an integrated end-to-end construct that can flex up or down in scope/scale
as programs evolve. Our deep domain expertise helps you solve your most complex
research problems.
END-TO-END SUPPORT
Reduce delays and drive consistency with dedicated, experienced program managers
and asset strategists who choreograph the dance of data, systems, teams and
vendors to ensure end-to-end continuity and trusted high-quality evidence and
experience.
FULL SERVICE CAPABILITIES
With global reach and scale, ProPharma offers an end-to-end suite of bespoke
solutions to ensure its clients have access to robust expertise and extensive
consulting resources across the full product lifecycle. Our team of experts and
strategists possess the knowledge and skillsets to support global clients at
every development stage.
CUSTOM SOLUTIONS FOR COMPLEX NEEDS
Click on a segment to learn more about our services
Click to learn more about regulatory sciences services
Click to learn more about clinical research solutions
Click to learn more about quality & compliance services
Click to learn more about pharmacovigilance solutions
Click to learn more about medical information services
Click to learn more about r&d technology services
*
*
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EXPLORE OUR CORE SERVICES
One size has never fit all. We’re here to offer a custom alternative that fits
your unique needs. A+ solutions scaled to your size. Each of our dedicated
service lines provides world-class critical consulting services that operate
autonomously across regulatory, safety, technology, and operations, but can
perform as an integrated whole.
Speak with an Expert
REGULATORY SCIENCES
ProPharma is the world’s leading regulatory sciences consulting firm offering
support across the full lifecycle for drugs, biologics, medical devices, and
diagnostics. ProPharma offers pre- and post-approval support for FDA, EMA, and
other national competent authorities.
Explore regulatory sciences services
CLINICAL RESEARCH SOLUTIONS
ProPharma offers industry leading support through a global team of trusted
experts for multi-phase clinical development and study execution focused on
drugs, biologics, medical devices, and diagnostics.
Explore clinical research solutions
QUALITY & COMPLIANCE
ProPharma is an industry leader in quality & compliance with decades of
experience in pharma consulting and regulation. ProPharma successfully brings
products to market through maintenance of quality and compliance standards and
records.
Explore quality & compliance services
PHARMACOVIGILANCE SOLUTIONS
ProPharma is an industry-leading organization comprised of pharmacovigilance
experts, offering a full suite of pharmacovigilance solutions to ensure safety
and consistency from clinical development through post-approval.
Explore pharmacovigilance solutions
MEDICAL INFORMATION
ProPharma provides comprehensive medical information services, including fully
integrated 24/7/365 contact centers. Our highly qualified medical information
specialists utilize market-leading technologies and innovation to help our
clients deliver current and accurate information and improve patient health and
safety.
Explore medical information services
R&D TECHNOLOGY
Science and technology have become increasingly intertwined, and unique
expertise is required to move your project through the development lifecycle to
completion. ProPharma helps life science organizations achieve technology
solutions that enable their products to get to market quickly and efficiently.
Explore R&D technology services
EMPOWERING OUR PARTNERS TO TRANSFORM SCIENTIFIC BREAKTHROUGHS TO LIFE-CHANGING
PATIENT OUTCOMES & THERAPIES.
Our team of experts have decades of experience across a wide variety of
therapeutic areas & specialties. We work as an extension of your team, bringing
you immediate resources who will align with your needs, processes, and
environment.
Therapeutic Areas
WE BRING THE SAME PASSION WE HAVE FOR PATIENTS AND HEALTHCARE SOLUTIONS TO OUR
EMPLOYEES.
Explore Careers
NEWS & INSIGHTS
Thought Leadership Press Awards Resource Library
FDA Modernization of Cosmetics Regulation Act (MoCRA)
March 9, 2023
MOCRA 2022: UPDATED REQUIREMENTS FOR COSMETIC COMPANIES
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics
since 1938. After 85 years of effectiveness the Modernization of Cosmetics
Regulation Act of 2022 or "MoCRA" was...
Read Full Article
FDA Rare Diseases
March 1, 2023
CHALLENGES IN CLINICAL DEVELOPMENT OF PRODUCTS FOR RARE DISEASE
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that
affect less than 200,000 people in the United States. There are over 7,000 rare
diseases affecting more than 30 million...
Read Full Article
Rare Diseases Orphan Drug Act
February 28, 2023
RARE/ORPHAN DISEASES AND THE AFRICAN AMERICAN COMMUNITY
How do we improve outcomes for an uncommon healthcare challenge in a community
challenged with common healthcare issues? The Orphan Drug Act defines a rare
disease as a disease or condition that...
Read Full Article
Press Releases
March 1, 2023
PROPHARMA ANNOUNCES THE APPOINTMENT OF KARL DEONANAN AS NEW CHIEF FINANCIAL
OFFICER
Raleigh, NC, March 1, 2023: ProPharma Group (ProPharma), the leading global
provider of regulatory, clinical and quality services for the life sciences
industry and a portfolio company of Odyssey...
Read Full Article
Acquisitions
February 6, 2023
PROPHARMA BUYS DLC IN LATEST SERVICES-FOCUSED TAKEOVER
On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter,
published a blog post mentioning ProPharma's recent acquisition of Digital Lab
Consulting (DLC) and ProPharma's release...
Read Full Article
Company News Acquisitions
January 25, 2023
PROPHARMA ANNOUNCES ACQUISITION OF DIGITAL LAB CONSULTING
PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING TO EXPAND
R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25,
2023: ProPharma Group (ProPharma) the...
Read Full Article
May 3, 2022
PROPHARMA GROUP NAMED TOP 10 CRO 2022 BY PHARMA TECH OUTLOOK
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric
Approach to Clinical Research Solutions ProPharma Group is honored to be named
Top 10 CRO 2022 by Pharma Tech Outlook...
Read Full Article
April 21, 2022
PROPHARMA GROUP NAMED BEST PHARMACEUTICAL REGULATORY & COMPLIANCE CONSULTANCY:
2022 CORPORATE EXCELLENCE AWARDS
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy:
2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best
Pharmaceutical Regulatory & Compliance...
Read Full Article
December 21, 2015
CONGRATULATIONS TO OUR 2015 COLLEAGUE AWARD WINNERS!
Each and every year, it continues to be a company tradition that we take a
moment to recognize a select few ProPharma Group colleagues who made a special
impact on our company and our clients...
Read Full Article
Infographic
June 10, 2022
THE COST OF POOR PROJECT MANAGEMENT
Project Management isn’t for the faint of heart. There is a shockingly high rate
of project failure… but on the other hand, great project management can be a key
differentiator that leads a company...
Read Full Article
Infographic
August 31, 2022
SUCCESSFULLY PASSING MHRA INSPECTIONS FOR OVERSEAS MANUFACTURING SITES
ProPharma Group offers GMP and GDP compliance services from clinical development
to commercial distribution of the products' lifecycle. ProPharma Group’s
Compliance and Quality team completed the...
Read Full Article
Infographic
October 4, 2021
NAVIGATING THE GENERIC DRUG APPLICATION AND APPROVAL PROCESS
Navigating the generic drug application and approval process can be challenging.
From pre-filing through post-approval, find out exactly what needs to be done
for your Abbreviated New Drug...
Read Full Article
NEWS & INSIGHTS
Press Awards Thought Leadership Resource Library
Company News Acquisitions
January 25, 2023
PROPHARMA ANNOUNCES ACQUISITION OF DIGITAL LAB CONSULTING
PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING TO EXPAND
R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25,
2023: ProPharma Group (ProPharma) the...
Read This Article
Press Releases
March 01, 2023
PROPHARMA ANNOUNCES THE APPOINTMENT OF KARL DEONANAN AS NEW CHIEF FINANCIAL
OFFICER
Raleigh, NC, March 1, 2023: ProPharma Group (ProPharma), the leading global
provider of regulatory, clinical and quality services for the life sciences
industry and a portfolio company of Odyssey...
Read This Article
Acquisitions
February 06, 2023
PROPHARMA BUYS DLC IN LATEST SERVICES-FOCUSED TAKEOVER
On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter,
published a blog post mentioning ProPharma's recent acquisition of Digital Lab
Consulting (DLC) and ProPharma's release...
Read This Article
Company News Acquisitions
January 25, 2023
PROPHARMA ANNOUNCES ACQUISITION OF DIGITAL LAB CONSULTING
PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING TO EXPAND
R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25,
2023: ProPharma Group (ProPharma) the...
Read This Article
Press Releases
March 01, 2023
PROPHARMA ANNOUNCES THE APPOINTMENT OF KARL DEONANAN AS NEW CHIEF FINANCIAL
OFFICER
Raleigh, NC, March 1, 2023: ProPharma Group (ProPharma), the leading global
provider of regulatory, clinical and quality services for the life sciences
industry and a portfolio company of Odyssey...
Read This Article
Acquisitions
February 06, 2023
PROPHARMA BUYS DLC IN LATEST SERVICES-FOCUSED TAKEOVER
On January 31st, 2023, Clinical Insider, a weekly clinical trials newsletter,
published a blog post mentioning ProPharma's recent acquisition of Digital Lab
Consulting (DLC) and ProPharma's release...
Read This Article
Company News Acquisitions
January 25, 2023
PROPHARMA ANNOUNCES ACQUISITION OF DIGITAL LAB CONSULTING
PROPHARMA ANNOUNCES ACQUISITION OF UK-BASED DIGITAL LAB CONSULTING TO EXPAND
R&D CAPABILITIES AND ACCELERATE PRODUCT DEVELOPMENT RALEIGH, NC, January 25,
2023: ProPharma Group (ProPharma) the...
Read This Article
May 03, 2022
PROPHARMA GROUP NAMED TOP 10 CRO 2022 BY PHARMA TECH OUTLOOK
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric
Approach to Clinical Research Solutions ProPharma Group is honored to be named
Top 10 CRO 2022 by Pharma Tech Outlook...
Read This Article
April 21, 2022
PROPHARMA GROUP NAMED BEST PHARMACEUTICAL REGULATORY & COMPLIANCE CONSULTANCY:
2022 CORPORATE EXCELLENCE AWARDS
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy:
2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best
Pharmaceutical Regulatory & Compliance...
Read This Article
December 20, 2015
CONGRATULATIONS TO OUR 2015 COLLEAGUE AWARD WINNERS!
Each and every year, it continues to be a company tradition that we take a
moment to recognize a select few ProPharma Group colleagues who made a special
impact on our company and our clients...
Read This Article
FDA Modernization of Cosmetics Regulation Act (MoCRA)
Mar 9, 2023 5:00:00 AM
MOCRA 2022: UPDATED REQUIREMENTS FOR COSMETIC COMPANIES
MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics
since 1938. After 85 years of effectiveness the Modernization of Cosmetics
Regulation Act of 2022 or "MoCRA" was...
Read This Article
FDA Rare Diseases
Mar 1, 2023 3:00:00 PM
CHALLENGES IN CLINICAL DEVELOPMENT OF PRODUCTS FOR RARE DISEASE
Rare diseases are defined in the Orphan Drug Act as diseases or conditions that
affect less than 200,000 people in the United States. There are over 7,000 rare
diseases affecting more than 30 million...
Read This Article
Rare Diseases Orphan Drug Act
Feb 28, 2023 5:00:00 AM
RARE/ORPHAN DISEASES AND THE AFRICAN AMERICAN COMMUNITY
How do we improve outcomes for an uncommon healthcare challenge in a community
challenged with common healthcare issues? The Orphan Drug Act defines a rare
disease as a disease or condition that...
Read This Article
Infographic
June 10, 2022
THE COST OF POOR PROJECT MANAGEMENT
Project Management isn’t for the faint of heart. There is a shockingly high rate
of project failure… but on the other hand, great project management can be a key
differentiator that leads a company...
View This Resource
Infographic
August 31, 2022
SUCCESSFULLY PASSING MHRA INSPECTIONS FOR OVERSEAS MANUFACTURING SITES
ProPharma Group offers GMP and GDP compliance services from clinical development
to commercial distribution of the products' lifecycle. ProPharma Group’s
Compliance and Quality team completed the...
View This Resource
Infographic
October 4, 2021
NAVIGATING THE GENERIC DRUG APPLICATION AND APPROVAL PROCESS
Navigating the generic drug application and approval process can be challenging.
From pre-filing through post-approval, find out exactly what needs to be done
for your Abbreviated New Drug...
View This Resource
Infographic
March 27, 2023
PATHWAYS TO MARKET FOR MEDICAL DEVICES IN THE U.S.
Medical devices are regulated by the Center for Devices and Radiological Health
(CDRH) at the FDA. Which approval pathway is appropriate for your product? You
have developed a medical device and are...
View This Resource
Case Study
October 14, 2021
ACCELERATE EUROPEAN MARKET ACCESS WITH COMPLIANT AND COMPREHENSIVE MAA
SUBMISSION
Preparedness for Marketing Authorization Application (MAA) approval ensures an
efficient application process and follow-up. Placing a medicinal product in the
European market requires a license for...
View This Resource
Case Study
February 3, 2022
AN INSPECTION-READY QMS ACCELERATES PRODUCT INTRODUCTIONS IN EUROPE
Accessing new market is in the European Union can be a challenge especially when
having to navigate both specific country and general European regulation. Read
how ProPharma Group used their deep...
View This Resource
Case Study
November 30, 2021
BESPOKE REGULATORY SCIENCES TEAMS FOR PHARMACEUTICAL COMPANIES
Sometimes there is sound logic for a pharmaceutical company to outsource a
significant part of their regulatory tasks to a stable and experienced team.
ProPharma Group’s team of Regulatory Sciences...
View This Resource
Case Study
March 18, 2022
OUTSOURCING QA - REDUCE TIME AND EXPENSE WHILE MEETING CRITICAL REQUIREMENTS
There is a tendency for VPCs to rely solely on the QC/QA units within their
outsourced CMO to perform quality functions. However, the sponsor organization
has the ultimate responsibility for product...
View This Resource
Case Study
October 4, 2021
CLINICAL MONITORING CHANGE MANAGEMENT
Translating regulatory guidance into success for your organization is difficult
when there is not a consistent industry standard. Coupled with new processes and
procedures within a company that has a...
View This Resource
Case Study
March 22, 2022
DECENTRALIZED VISITS IN RARE DISEASE STUDIES
Learn how ProPharma helped implement and execute decentralized visits for a
pediatric rare disease study. The COVID-19 pandemic caused major disruption to
many clinical trials and the participants...
View This Resource
Case Study
October 14, 2021
DEDICATED PROJECT MANAGER DIRECTS REGULATORY ACTIVITIES THROUGHOUT EUROPEAN
ECONOMIC AREA
Learn how a single point of contact oversaw local regulatory affairs activities
across all 31 countries of the EEA. You’re developing a drug, biologic, or
medical device product. There are a lot of...
View This Resource
Case Study
March 27, 2023
EARLY PHASE ONCOLOGY PROGRAM IN PATIENTS WITH SOLID TUMORS
See how we helped an emerging Biotech Sponsor achieve an enrollment rate and
average time to FPI that is well above industry benchmarks. An emerging Biotech
Sponsor needed management and full-service...
View This Resource
Case Study
November 12, 2021
EMA APPROVAL UNDER EXCEPTIONAL CIRCUMSTANCES
How we worked with an approved BLA to fit EU requirements for an MAA submission,
resulting in EMA approval. You’ve developed a novel drug and obtained FDA
approval. Your work is done, right? Not if...
View This Resource
Case Study
March 27, 2023
ENSURE DATA INTEGRITY COMPLIANCE TO PREVENT AUDIT FINDINGS
Ensuring accurate and honest data collection is essential for maintaining the
integrity of research. Even though the right mindset is the start of data
integrity compliance, that alone is not enough...
View This Resource
Videos
September 1, 2022
WEBINAR: AI-POWERED MI CONTACT CENTERS: KEY CONSIDERATIONS FOR A SCALABLE &
GLOBAL MEDICAL INFORMATION CAPABILITY
Today's Medical Information (MI) industry is being driven by evolving customer
behavior requiring a more rapid, omnichannel, and digital response to customer
needs. The expectation for higher...
View This Resource
Videos
June 27, 2022
INSIDER TALKS - TIPS FROM QUALIFIED PERSONS FOR SUCCESSFUL IMPORTATION
Which are the roadblocks impacting successfully obtaining a MIA for EEA/UK
Markets? You are in the process of obtaining an MA or CTA to bring your product
to EEA/UK markets, which can be a complex...
View This Resource
Case Study
October 14, 2021
ENSURE SUCCESSFUL ACQUISITIONS WITH COMPLETE AND ACCURATE REGULATORY DUE
DILIGENCE
Ensure you have as much information as possible to thoroughly evaluate the
potential investment when acquiring a company or product. When considering the
acquisition of a new company or product, it...
View This Resource
Case Study
October 14, 2021
ENSURE SUCCESSFUL BATCH RELEASE, REGULATORY COMPLIANCE WITH EXPERIENCED
QUALIFIED PERSONS
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU
batch release and USA inspection readiness. A contract manufacturing
organization (CMO) needs to have a reliable quality...
View This Resource
Case Study
October 14, 2021
EU MEDICAL DEVICE REGULATION PMO AND PROJECT DELIVERY
Regardless of your internal resources, it could be extremely taxing and
unrealistic to expect your team to accomplish both their normal daily activities
as well as the work necessary to ensure...
View This Resource
Case Study
November 2, 2021
GROWING A CULTURE OF QUALITY AND COMPLIANCE
One of the main challenges in adopting a global enterprise quality management
system is the complex nature of separate existing tools, applications, and
spreadsheets that companies often acquire or...
View This Resource
Case Study
March 27, 2023
HOW A TWO-PART NDA REGULATORY STRATEGY RESULTED IN SUBMISSION SUCCESS
Developing a New Drug Application (NDA) for submission to the FDA is an
extremely complex process and one that can present challenges to even the most
seasoned professionals. From ensuring you have...
View This Resource
Case Study
October 14, 2021
HOW TO ENSURE YOUR MULTI-MILLION DOLLAR SOFTWARE LAUNCHES ON TIME
Launching a large, enterprise technology solution with a global team is a big
undertaking for even the most experienced teams and largest companies.
Implementing a technology solution of this...
View This Resource
Case Study
June 1, 2022
HOW TO MANAGE A DRUG PRODUCT IN A MEDICAL DEVICE ENVIRONMENT
A global medical device company asked ProPharma Group to assess the set-up of
the entire supply chain of a drug product. We did so by reviewing the Global
Quality Management System and we determined...
View This Resource
Case Study
October 4, 2021
HOW TO MINIMIZE OVERDUE DEVIATIONS: A MULTI-SITE PROCESS IMPROVEMENT APPROACH
A global biopharmaceutical client with multiple sites operating under a Warning
Letter from the U.S. Food and Drug Administration (FDA) needed significant
cross-functional support to meet remediation...
View This Resource
Case Study
October 14, 2021
HOW TO SUCCESSFULLY LAUNCH PRODUCTS WITH QMS AND QP CERTIFICATION
Reaching patients in the EU with needed medicinal products is a complex
undertaking that not only requires knowledge of varied regulatory landscapes,
companies must also man, the services of a...
View This Resource
Case Study
October 14, 2021
IDENTIFY AT-RISK DRUG PRODUCTS AND ENSURE COMPLIANCE BEFORE NITROSAMINES
DEADLINE
Risk evaluation of products containing chemically synthesized APIs must be done
to assess adherence to nitrosamine regulations. Marketing Authorization Holders
(MAHs) must perform a risk evaluation...
View This Resource
Case Study
October 4, 2021
INCREASED VISIBILITY FOR SENIOR MANAGEMENT WITH CUSTOM PMO DESIGN,
IMPLEMENTATION
Time. Regardless of company size and the number of products in your portfolio,
time is one thing we could all use more of. However, the more projects you have
in your portfolio, the more stretched...
View This Resource
Case Study
October 14, 2021
INITIATING ENROLLMENT FOR ACCELERATED COVID-19 TREATMENT STUDIES IN 6 DAYS
In May 2020, as the FDA released new guidelines to accelerate the development of
novel COVID-19 therapeutics and vaccines, our Clinical Services experts were
asked to provide independent Data Safety...
View This Resource
Case Study
October 4, 2021
LABORATORY INFORMATICS WITH ROBOTICS
Workflows between Electronic Lab Notebooks (ELNs), Laboratory Information
Management Systems (LIMS), Scientific Data Management Systems (SDMS),
instruments, and robotics are immensely complex and...
View This Resource
Case Study
October 14, 2021
LACK OF FDA AUDIT FINDINGS DOESN’T NECESSARILY INDICATE VENDOR COMPLIANCE
When performing initial qualification audits, it’s important to evaluate all
critical systems evenly to ensure compliance. Lack of evaluation of all critical
systems can leave Sponsors and their...
View This Resource
Case Study
October 4, 2021
MANAGING COMPLEX PHARMACEUTICAL PROJECTS
There are many obstacles your team may face during product development. One of
the hurdles includes project management struggles associated with having too
many decision makers. Although it is one...
View This Resource
Case Study
October 14, 2021
MICC OVERFLOW SOLUTION WAS SUCCESSFULLY DEPLOYED AND PRESERVED CUSTOMER
SATISFACTION
A routine safety letter to HCPs was misinterpreted by recipients, causing a
“recall-like” crisis event for a multinational pharmaceutical client. When a
routine safety letter to healthcare...
View This Resource
Case Study
April 12, 2022
NAVIGATING QMS REQUIREMENTS FROM A MEDICAL DEVICE PERSPECTIVE
Having a different number of pharmaceutical classified products in your
portfolio provides a challenge in EU. As distribution and sales of MD products
are under MDR, while pharmaceuticals are under...
View This Resource
Videos
March 27, 2023
INSIDER TALKS - THE JOURNEY OF ATMPS FROM THE DISCOVERY TO ROUTINE GMP REAL LIFE
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers
face a range of scientific, technical, and regulatory challenges that can
quickly become overwhelming and costly. In...
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Case Study
October 14, 2021
OVERWORKED MEDICAL DEVICE TEAMS MISSING DEADLINES
Is your company experiencing rapid growth? Is your team overworked and falling
further and further behind? ProPharma Group’s team can help. You may recognize
that this is happening but not...
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Videos
May 19, 2022
INSIDER TALKS - TIPS TO ADAPT TO TODAY’S AUDITING ENVIRONMENT, AN AUDITOR’S
PERSPECTIVE
As businesses face the shared global challenges of adapting to new operating
models triggered by the recent pandemic, regulated drug and device sponsors,
marketing authorization holders, and...
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Case Study
April 25, 2022
PROGRAM AND PROJECT MANAGEMENT EFFECTIVELY DELIVER A QMS OPTIMIZATION PROGRAM
Given the challenging scheudules and competing priorities, companies have
minimal time to proactively address optimization of their QMS. There's very
little time for addressing prioritized...
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Videos
March 25, 2022
INSIDER TALKS - TO DECENTRALIZE OR NOT TO DECENTRALIZE … THAT IS THE QUESTION
Having a decentralized approach is critical to ensuring continuity in the face
of disaster, and important in meeting your overall enrollment goals while
increasing patient diversity. Join us for our...
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Case Study
March 21, 2022
REDUCED BURDEN FOR ONCOLOGY PATIENTS WITH DECENTRALIZED VISITS
Learn how our team helped implement decentralized visits for an oncology study
that reduced patient burden and stress on the sites. Oncology studies often
require frequent sample collection visits....
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Videos
February 4, 2022
AI-POWERED MEDICAL INFORMATION CONTACT CENTERS: KEY CONSIDERATIONS FOR A
SCALABLE & GLOBAL MEDICAL INFORMATION CAPABILITY
AI can enable MI Contact Centers to transform the customer experience using
digital avenues. Join us for our upcoming Insider Talks to find out!
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Case Study
October 14, 2021
SECURE TIMELY PRODUCT LAUNCH BY ENSURING GDP COMPLIANCE ACROSS EUROPE
Our client was in the phase of submitting a Marketing Authorization Application
(MAA) in the EU and needed to apply for a Wholesale Distribution Authorization
(WDA). After application and approval of...
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Case Study
July 26, 2022
SPONSOR SUCCESSFULLY COMPLETES ACQUISITION AFTER EFFICIENT PMA SUBMISSION
A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to
collaborate and support innovation to reduce complexity associated with a
successful PMA submission. Learn how...
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Case Study
October 14, 2021
STATISTICAL ANALYTICS WITH MACHINE LEARNING TOOL ENABLEMENT
Introducing new tools is difficult and comes with a learning curve for even the
most experienced, and having clearly defined processes and procedures is
critical to your team’s success. If there is...
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Videos
January 25, 2022
20 YEARS OF IMPROVING PATIENT HEALTH AND SAFETY
With our mission to improve the health and safety of patients, we are focused on
delivering the highest quality of services throughout the full product
lifecycle.
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Case Study
February 17, 2022
SUPPORTING DECENTRALIZED GENE THERAPY VISITS
Clinical trials often require frequent visits to the investigative site and
procedures which can be a turn-off or become the reason many patients cannot
commit their time to participate in a study. ...
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Videos
December 7, 2021
COHORT MANAGEMENT PROCESS AND PLANNING: CHALLENGES, RISKS, AND MITIGATIONS
Learn novel and useful drug design methodologies based on ProPharma Group's
years of experience navigating the risks, issues, and difficulties associated
with various cohort design studies.
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Videos
November 12, 2021
EXPEDITED PROGRAMS EXPLAINED: HOW TO EXPEDITE PRODUCT APPROVAL IN THE US AND
EUROPE
Could your product be eligible for one of these expedited programs? Join us for
our upcoming Insider Talks to find out!
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Case Study
October 14, 2021
TRANSFER AND MANAGE CLINICAL DATA PROVIDED BY MULTIPLE THIRD-PARTY VENDORS
Managing and sharing large amounts of clinical data provided by a team of ten
plus vendors is extremely challenging and requires meticulous attention to
detail and expert-level project management to...
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Videos
October 15, 2021
WHAT DOES IT TAKE TO BUILD A LEGACY? (20TH ANNIVERSARY VIDEO)
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Case Study
October 14, 2021
UNDERSTANDING CLINICAL TRIAL REQUIREMENTS FOR MEDICAL DEVICE LABEL EXTENSIONS
After you have developed an FDA-regulated product and obtained marketing
approval, you may think your job is done. However, after all the time, effort,
money, and so much more that goes into product...
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Case Study
October 14, 2021
USING SCIENCE TO ACHIEVE EMA APPROVAL FOR A FIRST-IN-CLASS INDICATION
See how a scientifically-driven strategy aided regulatory interactions, leading
to EMA approval for a novel oncology therapeutic. You’re developing a drug,
biologic, or medical device product. Your...
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Videos
October 13, 2021
THE TRUE COST OF NON-COMPLIANCE
How to avoid getting your first, second, and third warning letter from a federal
agency.
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Case Study
October 14, 2021
WHEN A TEAM LACKS INDUSTRY EXPERIENCE
Working with a team from three organizations across the globe is hard. Unifying
them required experts to take the lead. Working with a team that is spread
across the globe and made up of people from...
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Case Study
October 14, 2021
WHEN A TEAM LOSES THEIR LEADER AND LACKS A PLAN
Projects spanning multiple functions across an organization can be difficult to
execute and require the leadership of an experienced and organized project
manager. But what happens if the project...
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Videos
October 4, 2021
PROPHARMA GROUP OVERVIEW VIDEO
With our mission to improve the health and safety of patients, we are focused on
delivering the highest quality of services throughout the full product
lifecycle.
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Flyers
August 8, 2022
QP MIA SURVEY - PROGRESS SELF-ASSESSMENT
Use this readiness questionnaire to assess the current state of your progress.
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Whitepapers
March 21, 2022
MEETING THE FDA'S CAPA EXPECTATIONS
Year after year, findings of insufficient corrective and preventative action
(CAPA) procedures have topped the list of the most common observations found
during FDA inspections within the medical...
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Whitepapers
March 27, 2023
WHAT YOU NEED TO KNOW ABOUT REGULATORY PROGRAMS FOR EXPEDITED APPROVAL
Differentiating between the FDA and EMA's expedited approval pathways can be
tricky. Learn the similarities and differences between them to help determine
the best option(s) for your product. The...
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Flyers
February 3, 2022
EU IVDR PROGRESS SELF ASSESSMENT
The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to
assess the current state of your progress.
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Flyers
October 14, 2021
EMA SERVICES: ENSURE REGULATORY SUCCESS
Ensure Regulatory Success Across the European Medicines Agency (EMA) and
National Competent Authorities (NCAs)
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Flyers
March 27, 2023
ACCELERATING YOUR PRODUCT THROUGH DRUG DEVELOPMENT
Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients
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Flyers
October 14, 2021
CELL AND GENE THERAPY CENTER OF EXCELLENCE
Accelerating Your Product Through Development: Reducing Risk Ensuring
Compliance, and Accelerating Access for Patients
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Flyers
October 14, 2021
DATA INTEGRITY: THE QUALITY OF YOUR PRODUCT DEPENDS ON THE QUALITY OF YOUR DATA
Regulatory Agencies Expect Controls to Be in Place
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Flyers
October 14, 2021
FDA CONSULTING: REGULATORY STRATEGY EXPERTISE
Reduce Your Time to Market With an Effective FDA Regulatory Strategy
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Flyers
October 4, 2021
PROPHARMA GROUP SERVICES OVERVIEW
Improving Patient Health and Safety. At Every Step.
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Flyers
October 4, 2021
MEDICAL DEVICE DEVELOPMENT
Navigate Complex Global Requirements for Medical Device Approval
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Flyers
October 4, 2021
EU MARKET ACCESS: ACCELERATE MARKET ACCESS TO EUROPE WITH MIA LICENSE
Reduce Launch Timeline and Improve Business Efficiency
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Flyers
March 27, 2023
ENSURE PRODUCT QUALITY AND PATIENT SAFETY WITH THE RIGHT QUALITY MANAGEMENT
SYSTEM (QMS)
Save Time and Boost your Bottom Line
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eBook
October 17, 2021
OUTSOURCING OF MEDICAL INFORMATION CONTENT CREATION: EXPERIENCE OF 100 CLIENTS
The time and effort required to write, review, edit, approve, maintain,
distribute, and update Medical Information (MI) documents while retaining an
auditable record of the search strategy is a great...
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Whitepapers
October 14, 2021
GOOD SCIENCE PRESENTED WELL GENERATES APPROVAL
Without good data, any application has little chance of success. Working with a
regulatory consultant that has an excellent understanding of the science and how
to present it properly is the surest...
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Whitepapers
October 14, 2021
HOW TO COMPILE A SCIENCE-BACKED NEW DRUG APPLICATION (NDA) SUBMISSION
Developing a successful NDA is critical to the success of your product and
company. Learn how to develop a science-focused submission like an expert with
these six tips. You are getting ready to...
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Whitepapers
October 14, 2021
A GUIDE FOR EFFICACIOUS DATA INTEGRITY DURING COVID-19
Learn how ProPharma Group implements data integrity measures to prevent
reputation damage, unsafe products, and costs. With the current pandemic
creating schedule delays, interrupting supply chains,...
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eBook
October 14, 2021
EVOLVING EMEA MI SERVICE MODELS
There are 116 countries in the EMEA region and around 24 languages spoken, how
do you know what structure and model are best for each client and how do you go
about making it happen? There are so...
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Whitepapers
October 13, 2021
WHAT YOU NEED TO KNOW ABOUT GXP INDEPENDENT COMPLIANCE AUDITS
Simply having the appropriate standard operating procedures (SOPs) in place is
not good enough; procedures must be followed to the letter. Prevent the
consequences of quality systems being...
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eBook
October 4, 2021
OUTSOURCING MEDICAL INFORMATION SERVICES: WHEN TO CONSIDER A DEDICATED RESOURCE
Outsourcing Medical Information (MI) services can be an effective solution for
ensuring the provision of MI services to HCPs and consumers globally. The most
cost-effective model for the provision of...
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eBook
October 4, 2021
IMPROVING PRODUCT QUALITY DURING TECHNICAL TRANSFERS
Is your product quality at risk during a tech transfer? Now, more than ever,
companies are transferring products and processes from one site to another,
often facing pressures on time, resources, and...
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Flyers
March 23, 2023
6 KEY ELEMENTS OF SUCCESSFUL DRUG & DEVICE DEVELOPMENT IN EUROPE
Navigating EMEA and Country-specific regulations is both confusing and a mammoth
task. The EU regulatory system has around 50 regulatory authorities for 31
different countries, making it difficult to...
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NEXT PROPHARMA EVENT
Our team has a consistent pulse on industry changes, the evolving marketplace,
and patient needs. We are excited to attend several events in 2023. We look
forward to meeting you to share new insights, explore new perspectives, uncover
unmet business needs, and continuing professional development.
BIO-EUROPE SPRING 2023
March 20, 2023 - March 23, 2023
Reconnecting and Facilitating Global Partnerships Meet your next strategic
partner at Europe's largest springtime partnering event. The seventeenth annual
springtime partnering conference is back face-to-face. Reconnect with key
stakeholders from across the industry and form meaningful partnerships. March
20–22, 2023 | Basel, Switzerland, https://informaconnect.com/bioeurope-spring/
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