Global Regulatory Affairs Integrated Clinical Development

Integrated across six continents, PPD helps you ensure the success of your multinational clinical development programs by providing strong regulatory strategy globally and in-depth local and regional regulatory knowledge.

PPD builds on more than 25 years of clinical and regulatory experience and expertise as well as trust-based relationships with national and regional regulatory authorities to support all aspects of regulatory affairs for our clients. Our far-reaching experience and global integration allow us to monitor proactively for potential risks and challenges. We anticipate and address queries raised by local regulatory authorities in advance to facilitate the efficient review of applications, maximizing the probability of a successful and speedy outcome.

Regional Expertise

North America

For more than 25 years, our global regulatory affairs group in the United States and Canada has combined institutional knowledge, in-depth therapeutic expertise and robust feasibility tools to help clients define and develop their products, minimize delays and execute high-quality, cost-efficient regulatory services.

Europe, Middle East and Africa

PPD has a strong footprint in Europe, the Middle East and  Africa that is driven by regulatory affairs personnel with more than 15 years of regulatory experience. Our local teams leverage robust regulatory knowledge of the European Medicines Agency as well as national authority requirements to optimize study start-up.

Latin America

Latin America is a major emerging market for clinical development. PPD has a strong presence in this region, with more than 25 dedicated regulatory affairs personnel supporting clients in 15 countries. Our regulatory team in Latin America has a robust understanding of diverse local regulations and a strong trust-based relationship with individual regulatory authorities.

Asia Pacific

This nonharmonized region demands deep and constant contact with government, environmental and regulatory authorities to ensure accurate interpretation of current requirements. PPD has dedicated regulatory affairs personnel in seven offices across Asia Pacific. We offer clients local resources and a variety of clinical services in Asia Pacific countries, including one of the largest and most experienced regulatory teams in China.

Global Regulatory Affairs Systems

PPD maintains a powerful, Web-based system for global submissions management, including planning, tracking and status reporting. Our regulatory and ethics submission planning tool is:

• Fully integrated with our global regulatory intelligence system
• Replete with the most up-to-date information on document requirements for both agency and ethics committee (EC) submissions in more than 70 countries
• Capable of direct connectivity with our clinical trial management system, ensuring relevant country/site information is validated and consistent across both systems.

Our global regulatory affairs network, global and regional geographic reach, and experience and knowledge are at your disposal for all of your regulatory clinical development, licensing and post-approval needs.