Promotional Review & Labeling
ProPharma has built the world’s leading and first, full-service organization dedicated to global Advertising, Promotional Review, & Labeling Services.
Advertising & Promotional Review Services
ProPharma has built the world’s leading and first, full-service organization dedicated to global Advertising & Promotional Review services. Led by industry veterans and thought leaders, we help our clients develop compelling and compliant messaging in an efficient manner to grow their brands. With comprehensive promotional review capabilities – from Medical and Regulatory Review, technology solutions, marketing operations, to regulatory submission, and beyond – we take a flexible approach to meet our clients’ business objectives. Our expert team highlights include:
- Global leader in Promotional Review Committee (PRC) support, having helped launch hundreds of brands and supported thousands of PRCs (US, EU, Asia, etc.)
- Deep experience in pharmaceutical, biotechnology, vaccines, medical device (Class I, II, III), OTC drugs, nutritional supplements, animal health and cosmetic products
- Collaborative professionals who launch new products (pre-approval, launch and post-approval brand support), support growing brands, and legacy products
- Full-service, including PRC establishment and resourcing, system configuration and implementation, SOP generation, medical fact-checking, training and mentoring, PRC process assessment and improvement
End-To-End Promotional Review Services
Medical Review
- Expert consultant team to manage day-to-day review responsibilities, without sacrificing scientific accuracy or integrity; each of our individual consultants is part of an organization of over 50 experts that provides the support and feedback that is required to meet your brand’s challenges
- Promotional and Medical Review Committee participation (PRC/LMR/MLR)
- Medical accuracy and evidentiary standard review (substantial evidence, competent and reliable/FTC)
- Broad therapeutic experience
Regulatory Review
- Experienced and collaborative regulatory professionals
- Office of Prescription Drug Promotion (OPDP) or Advertising and Promotional Labeling Branch (APLB) product advisory comment submissions –authoring, editing, and preparation
- Extensive Accelerated Approval (Subpart H) launch experience
- Successful interactions with regulatory authorities
- Guide teams through regulations, guidance documents and enforcement communications
- Deep understanding of trial design and outcomes
Marketing Operations
- Commercial Operations Infrastructure Build & Support (Policy, Process, and Procedure Development)
- Promotional Material, Medical, Legal, Regulatory (MLR/PRC) Review Process Management (PRC Coordinator)
- Experienced resources to maintain efficient collaboration in cross-functional teams
- Review System implementation and configuration
- Experience with all e-review platforms
Global Labeling
ProPharma is the leading provider of global label services for pharmaceutical, biotechnology, medical device (Class I, II, III), nutritional supplements, animal health and cosmetic products. We have unmatched expertise across regions, areas of therapy, and product types. Our team works with our clients to support and enhance their brands, whether that requires expertise in regulatory strategy, label operations, or technology. Our Global Labeling Team can support your needs in the following areas:
- New product label strategy development and negotiations (FDA, EMA, Rest of World)
- Lifecycle management (label expansion, global submissions)
- Global label process establishment, assessment, and improvement
- Target Product Profile (TPP)
- Company Core Data Sheets (CCDS)
- U.S. package inserts
- Medication guides
- Summary of Product Characteristics (SPC)
- Patient Information Leaflets (PIL)
- Structured Product Labeling (SPL) submission
Partner with us!
Complex Needs Require Custom Solutions
ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.
Client Feedback
"The ProPharma Group has been a valued and trusted partner as our Medical Information third party call center for a number of years. During that time they have exhibited the highest level of quality, compliance, and professionalism. Always keeping the needs of our mutual customers front and center. The team is diverse in their staff and their offered services, which enables us to customize support to business need. We would highly recommend the services of ProPharma without hesitation.”
Laurie Wingett - Bayer, Inc.
Medical Affairs Head, Primary Care (WH/established brands) and Medical Operations
“Working with Pro Pharma has been a pleasure. The auditors are friendly, knowledgeable, and communicative. They have been a great resource to help us complete a wide range of audits and
manage our supplier quality.”
Emily King - Azurity Pharmaceuticals
"Working with the whole team at ProPharma Group has been an honor. For several years they have acted on our behalf as a trusted customer facing vendor for medical information inquiries. their subject matter expertise, collaborative nature and high level of professionalism have been a bellwether for us through all stages of marketing and scaling a new drug product. The next time my team is in need of scientific communication outsourcing, PPG will be my first stop."
Jenny Strauss - Biohaven Pharmaceuticals
Manager, Medical Information and Communications
“Lyell engaged Pro Pharma as our validation partner as we built and qualified the LyFE Manufacturing Center. Pro Pharma assisted in all phases of the qualification including establishing the facility and equipment qualification program, protocol generation, protocol execution, and writing the final reports. They played a critical role in getting the facility ready on time and on budget to support the Lyell clinical trials.”
David Shank - Lyell Immunopharma, Inc.
Vice President, Manufacturing
When we partnered with Oxford University to enable global development, manufacturing and distribution of our vaccine, we put broad and equitable access at the heart of our response. The result was a vaccine that was developed in under a year, and we believe we have made a significant impact in terms of global public health. Based on data published in The Lancet and an analysis by Airfinity, our vaccine is estimated to have saved over 6 million lives in the first year of vaccination.
AstraZeneca supplied the vaccine with no profit during the pandemic and we are supplying the vaccine with no profit in low-income countries today. To date, over 3 billion doses have been released for supply to more than 180 countries. AstraZeneca was the first and largest contributor in 2020 and 2021 to COVAX, with over 470 million doses. Doses that couldn’t have been released without the partnership with ProPharma. In our collaboration an estimated 500 million doses underwent thorough quality assessment to provide a vaccine made for the world.
Pythia Segers - Astra Zeneca
"We have had the pleasure of working with ProPharma on a global scale for several years assisting us with Medical Information Call Center and writing workflows. Their ability to adapt based on the client’s needs is very commendable. Also, we are fortunate to work with a very talented team of professionals who are always eager to work with us and deliver quality service to our customers."
Anonymous
News & Insights
October 2, 2025
Medical Information in the Netherlands: Safeguarding Compliance and Patient Conf...
Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.
September 30, 2025
Tips for Preparing Successful FDA 510(k) Submissions
Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.
September 26, 2025
FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...
Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
October 6, 2025
Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...
When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...
-chcecklist-complete-guide-fda-510k-submissions-ppg.png?width=320&height=185&name=510(k)-chcecklist-complete-guide-fda-510k-submissions-ppg.png)
September 30, 2025
Your Complete FDA 510(k) Premarket Notification Checklist
Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....
September 19, 2025
Unannounced FDA Inspections Without Borders
Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...
November 18, 2025
Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions
Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions,...
November 11, 2025
Tips for Successful MAA Submissions in Europe
Navigate the complexities of EU marketing authorization to explore tips for successful Marketing Authorization Application (MAA) submissions in Europe to ensure proven strategies, reduced delays, and...
October 16, 2025
AI in Medical Information: Who Holds the Responsibility?
In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...
News & Insights
October 2, 2025
Medical Information in the Netherlands: Safeguarding Compliance and Patient Conf...
Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.
September 30, 2025
Tips for Preparing Successful FDA 510(k) Submissions
Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.
September 26, 2025
FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...
Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 24, 2024
ProPharma Honored in the 2024 Clinical Trials Excellence Awards
ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.
October 6, 2025
Critical Database Lock Milestone Achieved Through Rapid FSP Support for BioXcel ...
When BioXcel Therapeutics’ pivotal Phase 3 study faced a critical slowdown, timelines and regulatory goals were at risk. With their primary CRO unable to meet growing demands, ProPharma stepped in —...
September 30, 2025
Your Complete FDA 510(k) Premarket Notification Checklist
Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....
September 19, 2025
Unannounced FDA Inspections Without Borders
Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...
November 18, 2025
Navigating the New EU HTA Regulation as an MAH: Strategic Insights for Successful JCA Submissions
Explore how the new EU HTA Regulation (EU HTAR) is transforming market access across Europe. Join our expert to learn practical strategies for successful Joint Clinical Assessment (JCA) submissions,...
November 11, 2025
Tips for Successful MAA Submissions in Europe
Navigate the complexities of EU marketing authorization to explore tips for successful Marketing Authorization Application (MAA) submissions in Europe to ensure proven strategies, reduced delays, and...
October 16, 2025
AI in Medical Information: Who Holds the Responsibility?
In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...