Advertising & Promotional Review Consulting

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Global Leader in Advertising and Promotional Review

ProPharma has built the world’s leading and first full-service global solution dedicated to Advertising & Promotional Review. Our unique end-to-end solutions are establishing a new standard in the industry, helping our clients achieve their objectives efficiently and effectively. Our comprehensive capabilities include global expertise in regulatory review, medical review, legal review, marketing operations, and regulatory operations for a full solution that can be deployed together or by selecting the expert capability that complements your current team, process, and review system.

Our Expert Team Highlights Include:

Global leader in Promotional Review Committee (PRC) support, having helped launch hundreds of brands and supported thousands of PRCs in all major regions around the world (US, EU, Asia, etc.)

Deep experience in pharmaceutical, biotechnology, vaccines, medical device (Class I, II, III), over the counter (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, and PRC process assessment and improvement

ProPharma is Proud to be a Veeva Services Partner.

Our end-to-end solutions include proficiency in multiple electronic review systems including Veeva Vault. We are an official Veeva Services Partner.

Learn More about Veeva

End-to-End Promotional Review Consulting Services

Medical Review

Regulatory Review

Legal Review

Marketing Operations

Regulatory Operations

Medical Review

Our team of expert medical reviewers and consultants manage day-to-day review responsibilities, without sacrificing the scientific accuracy or integrity of your promotional materials. 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.

Our team of medical review consultants possess broad therapeutic experience as well as global review capabilities, including:

Medical review for commercial materials (e.g., promotional, unbranded, disease-state awareness materials), including "live" participation at PRC/LMR/MLR meetings
Medical review for medical-only/non-promotional materials (e.g., MSL materials, posters, abstracts, oral presentations, manuscripts, clinical trial recruitment materials)
Medical and scientific accuracy review of content and claims
Medical accuracy and evidentiary standard review (substantial evidence, competent and reliable/FTC)
Data QC
Medical fact-checking
Evidence referencing for new and updated content

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Regulatory Review

Our team of regulatory reviewers establishes an industry benchmark for expertise and collaborative excellence. Each reviewer brings a rich diversity of experience from working across all therapeutic areas within large, mid-size and small companies. This breadth of experience positions them as trusted partners, instrumental in driving the success of our clients’ projects. They are more than just reviewers; they are strategic allies in the promotion of healthcare products.

Our team of regulatory review consultants is comprised of experts with extensive global experience, including the following capabilities:

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

Legal Review

Our team of legal reviewers assists clients in navigating complex legal landscapes, enabling them to make well-informed decisions that help reduce risk. These experts ensure that all promotional activities adhere to federal and state laws, as well as industry codes and guidelines. This protection goes beyond merely avoiding penalties; it is crucial for maintaining the trust and integrity of the company's brand and products.

Our team of legal review consultants has extensive experience and capabilities, including:

Team of experienced legal practitioners
Provides expert advice on the legal risks associated with promotional materials and practices
Compliance with federal and state laws, industry codes and guidance
Areas include copyright, trademarks, fraud and abuse, and anti-kickback issues

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Marketing Operations

Our Marketing Operations managers excel in facilitating collaboration across medical, legal, regulatory, and marketing teams. They are skilled at streamlining communication and expediting decision-making processes, especially during critical commercial launch activities. By strategically partnering with our clients' internal stakeholders, we customize processes to suit your organizational needs and adhere to industry best practices.

The experts on our team of marketing operations consultants have experience with the following:

Commercial operations policy, process, and procedure development
Promotional review process management
- Coordinator services
- PRC/LMR/MLR meeting facilitation
- Editorial services
Expert resources to maintain efficient collaboration in cross-functional teams
E-review system implementation and configuration
All e-review platforms

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Regulatory Operations

Regulatory operations is a critical component of any regulatory submission, as this is the team that ensures the submission is in a format that FDA can receive and read. However, our team of regulatory operations consultants takes a unique approach to compiling FDA submissions. Comprised of experts with decades of experience compiling successful submissions, we are able to take all of the documents our clients have and put them in the right spot without requiring any additional administrative work on your end.

In addition, our team of regulatory operations consultants assist with the following:

Provides expertise and guidance on all submissions
Manages timelines and content
RIM data management
Process mapping/development
FDA Form 2253 Preparation and Submission for Promotional Materials
- Submission coordinator/binder services
- 2253 eCTD submission services

Explore our Regulatory Operations Consulting Services

Global Labeling Resources + ProPharma's Prodigy Label Technology

ProPharma is the leading provider of technology-enabled 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, therapeutic areas, and product types as well as the ability to leverage our proprietary technology- Prodigy Label. This allows our team to help you develop best-in-class and innovative labeling more efficiently and effectively. Our team works with our clients to support and enhance their brands, whether that requires expertise in regulatory strategy, label operations, or technology.

Global Labeling Capabilities

Our team of global labeling consultants can support your team in the following areas:

New product label strategy and development, and health authority negotiations (FDA, EMA, Rest of World)
Lifecycle management (label expansion, maintenance of growth and established brands, global submissions)
Global label process development, assessment, and improvement
Target Product Profiles (TPP)
Company Core Data Sheets (CCDS)
S. package inserts & Medication Guides/Patient Package Inserts (PPI)/Patient Medication Information (PMI)
Summary of Product Characteristics (SPC)
Patient Information Leaflets (PIL)
Structured Product Labeling (SPL) submission

The World's Leading Regulatory Consultancy

ProPharma’s team of advertising and promotional review consultants can help with all of your advertising and product promotion-related needs. Contact us today to learn about our track record of success with the regulatory agencies over the last 40 years and discuss how we can help you get to the next regulatory milestone.

Talk to an Expert

News & Insights

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June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Read This Article

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

Read This Article

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Read This Article

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Read This Article

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Read This Article

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ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Read This Article

July 2, 2024

The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 2

Explore the evolving regulatory landscape for Gene Therapy Trials in the EU with our guide on the new submission requirements for the Summary Notification Information Format.

Read This Article

July 1, 2024

The Moving Regulatory Landscape for Gene Therapy Trials in EU: Part 1

Explore the regulatory complexities of gene therapy clinical trials in the EU and the benefits of the CAF for GMO applications. Learn how ProPharma's expertise can guide you through the GMO...

Read This Article

July 1, 2024

5 Key Challenges in the Development of Gene Therapies

Key challenges in gene therapy development include nonclinical efficacy, CDMO partner selection, payor pre-approval, clinical trial endpoints, and site selection.

Read This Article

Infographic

June 10, 2022

The Cost of Poor Project Management

View This Resource

Infographic

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

View This Resource

Infographic

October 4, 2021

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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