Global Regulatory Services

PPD provides comprehensive regulatory services across the spectrum of global product development, registration and commercialization. With regulatory experience spanning all areas of pharmaceuticals, our global regulatory experts provide intelligence and strategic insight to optimize your product’s success.

Worldwide Reach for Proactive Regulatory Affairs Strategies

Regulatory affairs professionals located in more than 25 countries give PPD the global reach and active regulatory agency network to provide local coverage in most key markets. This enables us to apply up-to-date, robust regulatory intelligence to product development and registration strategies.

The global regulatory affairs group develops preemptive solutions for potential regulatory hurdles and ensures the quality of submissions to worldwide agencies to maximize the likelihood of successful review.

Led by industry-leading regulatory experts, PPD’s global regulatory affairs group provides a comprehensive spectrum of services, including:

Global Regulatory Development Services

PPD’s global regulatory development team is strategically located across six continents. Our focus is on helping you understand and adhere to regulatory guidelines and address the clinical development and lifecycle management needs of your products.

Regulatory Consulting and Intelligence Services

Enable and enhance your regulatory capabilities with our global footprint and proprietary intelligence information. Our expert subject matter consultants assess strategies and risks and provide development plans to maximize success.

Chemistry, Manufacturing and Controls (CMC) Services

PPD's global resources and expert staff help you create CMC/toxicology programs that are fully integrated with the clinical and regulatory components of your drug development program.

Medical Device and Diagnostics Services

Our device and diagnostic team provides a full range of consulting and agency liaison services to secure product approval, facilitate fast and cost-effective market entry, and ensure continued compliance throughout the life cycle of your device and diagnostic products.

Medical Writing and Quality Review Services

Our medical writing team develops clear, concise, scientifically and medically accurate documents that are fully compliant with regulatory requirements to speed your product through approval.

Publishing and Submission Management Services

PPD’s team of publishers brings strong regulatory affairs knowledge to plan, compile, track and manage submissions to global regulatory authorities. We can adhere to any regional format for all types of applications (CTD/eCTD/NeeS/Paper) to meet important product development milestones.