Regulatory Affairs

PRA's Regulatory Affairs team has daily-use knowledge of regional regulatory requirements across the globe. We offer competitive product development plans, rapid study startup and effective submissions strategies. This is possible through close collaboration with multi-functional project teams that support Early Clinical Trial Development, Product Registration and Late Phase trials. Our partnership with PRA's Analysis & Reporting and Safety & Risk Management groups has proven instrumental in ensuring successful development programs.

We provide global consulting services and develop strategies for the registration of clinical trials for:

• Novel products
• Biotechnology therapeutics
• Advanced therapeutics for a broad range of products:
  • New chemical entities
  • Biologicals
  • Medical devices

Our teams have scientific backgrounds and other significant experience from:

• Other CROs
• Regulatory Agencies
• Academia
• Pharmaceuticals and Biotechnology Industries

PRA offers the following regulatory services covering all aspects from discovery to all phases of clinical development, to market approval, and leading into the post marketing studies:

• Regulatory lifecycle management
• Regulatory strategic development
• IND/CTA submissions/maintenance
• SPA/Orphan Applications
• Agency meeting preparation
• Marketing authorization applications
• Agency Liason

PRA's dedicated Regulatory Publishing Group provides a full spectrum of regulatory submission services ranging from rapid production of paper-based submissions to expertise in Electronic Submissions Publishing. As more agencies move to requiring electronic submissions, PRA's publishing group provides services for the preparation of a complete eCTD submission. PRA also provides eCTD submission life-cycle management, which includes appending and replacing files in current eCTD submissions or subsequent amendments.