Advertising & Promotional Review Consulting
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.
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
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
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
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
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.
News & Insights
December 10, 2024
FDA Releases Final ICH M13A Guidance Document
FDA recommendations for conducting BE studies, efficiency improvements in global drug development, and how ProPharma can assist with your regulatory needs.
December 9, 2024
The Evolving Landscape of Quality Management Systems in the Life Sciences Industry
Discover the evolving landscape of Quality Management Systems in the life sciences industry and how to navigate modern regulatory challenges.
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.
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.
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.
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...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights