USA Specific Solutions

RPN helps navigate Food and Drug Administration (FDA) regulations and provides strategic advice and operational support for all key FDA regulatory Designations and Procedures, including scientific writing assistance for the preparation, revision, and updating of key documents, if needed.

Specific US FDA solutions include:

• Local Agent role.
• Investigational New Drug (IND) application.
• Meetings with the FDA, including Pre-IND Meetings and End of Phase 2 (EOP2) Meetings.
• Orphan Drug Designation (ODD).
• Priority Review Designation.
• Breakthrough Therapy Designation.
• Fast Track designation.
• New Drug Application (NDA).
• Biologics License Application (BLA).
• Initial Pediatric Study Plan (iPSP).
• Submission to the FDA (Electronic Submission Gateway).