FDA SUBMISSIONS & MEETINGS

​The NavonPharma Group Consultants provide direction through the entire life cycle of the regulatory submission and FDA communication process.

Our consultants are FDA experts and have extensive industrial experience. 

 FDA Submission Services:

• FDA Regulatory Document Preparation & Review (pre-IND, IND, NDA, ANDA, BLA).​​
  
• Planning and conducting of pre-IND, End of Phase 1 and 2, pre-NDA/BLA submission meetings as well as Type A and Type C meetings.​
  
• Preparation and/or review of FDA briefing documents for FDA meetings.

• Request for Orphan Drug Designation, Pediatric Rare Disease Designation and Special Protocol Assessment request.