Regulatory Affairs Consulting

PPD’s strategic regulatory consulting team is comprised of seasoned pharmaceutical industry senior regulatory experts with extensive multiregional experience in product development and strategic planning, execution and achievement of successful product registration with regulatory authorities worldwide.

Our team develops and manages product- and indication-specific regulatory strategies that enable the most efficient registration pathway(s) and yield a high probability of approval success. Our consultants draw upon PPD’s internal regulatory affairs knowledge and expertise in preclinical; chemistry, manufacturing and controls (CMC); and clinical and commercial development to build strategies that meet the demands of a dynamic regulatory environment.

We offer a complete spectrum of comprehensive regulatory consulting services including:

  • Strategic consulting and intelligence
  • Negotiate/Interact with regulators
  • Marketing application preparation
  • Clinical trial applications
  • Medical devices
  • Lifecycle management
  • Preclinical and CMC consulting

Comprehensive Regulatory Expertise across the Therapeutic and Drug Development Spectrum

Our senior regulatory professionals hold advanced academic, scientific credentials and are knowledgeable in early- and late-stage drug and device development across many therapeutic areas, including, but not limited to, oncology, neuroscience, cardiovascular, metabolic, respiratory, infectious diseases, and inflammatory and immunological diseases.

Application of Critical Regulatory Knowledge, Expertise and Negotiation Skills that Maximize Approval Success

Our drug and device regulatory experts minimize delays and increase efficiency with regulator reviews by providing ongoing surveillance of regional and local legislation, regulations, directives, guidelines and regulatory approval precedents to ensure creativity and rigor in product development and registration planning. Further, our team is experienced at interacting with regulatory agencies around the world for pre-application milestone and scientific advice meetings, application defense and labeling negotiations. Our industry experience in supporting the creation of marketing applications ensures continuity in key messaging across application components.

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