Regulatory Strategic Consultation

PRA's professionals submit applications to regulatory authorities in over 60 countries around the world. Our intimate local knowledge insures compliance with regulatory requirements and helps to expedite approvals. We provide strategic and technical consultations for Clinical Trials Applications (CTA) and associated reporting requirements.

Our Regulatory Strategic Consultation services span pre-clinical to post-marketing, and include:

• Global Consultation for Pharmaceuticals, Biologics and Devices
• Regulatory Consultation for approval/registration requirements
• Regulatory Strategic Plan Development
• Agency Meetings coordination and representation
• Gap Analysis and Assessment of Scientific & Technical Data for various submissions/applications
• Due Diligence assessments
• Labeling support: Target labeling – physician and patient text
• Consultation and support for Orphan Drug, Fast Track and Pediatric Applications
• Consultation and support for Marketing Applications including CTD format
• Consultation and support for all interactions with Regulatory Authorities
• Regulatory Intelligence