Regulatory Affairs Strategy and Meetings

PPD’s experienced regulatory professionals assist with the development of regulatory strategies and are available to lead and participate in regulatory authority meetings. With extensive expertise honed through the preparation of a vast array of successful development plans, our regulatory affairs staff helps speed your drug development investment.

Experienced Regulatory Affairs Leadership

PPD can help improve the likelihood of product authorization by regulatory authorities. Our experienced leadership can:

• Provide strategic development advice and targeted assistance
• Facilitate the development of effective product labels
• Develop competitive intelligence surveys, including review and appraisal of the relevant regulatory environments and guidelines
• Define and refine regulatory development plan content
• Represent or support interactions and negotiations with regulatory authorities

Regulatory Meetings Expertise and Support

We offer a variety of services that support interactions and meetings with regulatory authorities including:

• Preparing briefing packages for regulatory meetings
• Compiling post-meeting analysis, responses and dispute resolutions
• Maintaining archived files of all regulatory authority correspondence
• Training and coaching of clients’ employees

Global Reach and Understanding

With experienced regulatory professionals in North America, the European Union, Latin America and Asia, PPD is capable of serving as an experienced, diplomatic and effective liaison with all major global regulatory authorities. We also assist with the preparation of complex global regulatory development strategies.