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

Woman in lab coat wearing headset stethoscope typing on laptop

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

Business Professionals pointing at papers with their fingers

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

Hands gesturing around a table with various charts and graphs

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

Thought Leadership Webinars Press Awards Resource Library

August 28, 2025

Why MI Experts Can Reduce Operational Burden for Pharma Companies

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July 8, 2025

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January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

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October 21, 2024

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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.

Read Full Article

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.

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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.

Read Full Article

View all Awards

Case Study

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

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Case Study

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

Read Full Article

Case Study

July 29, 2025

Successfully Executing a Tech Transfer in a Week

Discover how ProPharma supported a $3B pharmaceutical tech transfer that was executed in just 3 days, relocating five complex product lines. The plan included FDA alignment, pre-approved protocols,...

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September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

July 29, 2025

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Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

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News & Insights

August 28, 2025

Why MI Experts Can Reduce Operational Burden for Pharma Companies

Discover how partnering with MI experts at ProPharma can reduce operational burdens, enhance compliance, and improve efficiency for pharmaceutical companies.

Read This Article

August 26, 2025

Maximizing Clinical Trial Success: Strategic Approaches for Adding EU Member Sta...

Successfully expand clinical trials to additional EU Member States under the CTR framework. Explore strategies for patient recruitment, regulatory compliance, and minimizing CTIS approval delays.

Read This Article

August 25, 2025

Selecting a PMPV Vendor, Part II: Building on a Strong Foundation

Discover the essentials of selecting the right pharmacovigilance vendor for post-marketing safety, ensuring compliance, flexibility, and effective signal detection.

Read This Article

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...

Read This Article

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.

Read This Article

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.

Read This Article

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.

Read This Article

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.

Read This Article

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.

Read This Article

Case Study

August 21, 2025

From Local Limits to Global Integration: Transforming Medical Information Servic...

Discover how ProPharma transformed medical information services in Japan by integrating global alignment with localized expertise. By harmonizing processes, cross-training teams, and tailoring...

View This Resource

Case Study

August 4, 2025

Simplifying Global MLR Review: Local Expertise at a Global Scale

Struggling to streamline MLR review across international markets? Discover how our team helped a leading pharmaceutical company reduce review timelines, ensure regulatory compliance, and eliminate...

View This Resource

Case Study

July 29, 2025

Successfully Executing a Tech Transfer in a Week

View This Resource

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

September 17, 2025

The Path to Clarity – Unlocking the Power of Data Standards for Digital Transformation

In today’s data-driven R&D environment, fragmented and incompatible data can stall innovation. This webinar, led by experts from ProPharma and CSL Behring, reveals how robust data standards,...

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Watch the Replay