Promotional Review & Labeling

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