Omni-EDS Regulatory Strategy & Representation services include:

• Guidance for new drug, biologic or medical device regulatory strategy
• Advice on regulatory options and pathways
• Review, support and creation of regulatory submissions
  • Pre-IND, IND, Clinical Study Reports, 510Ks
• Accelerated approval pathways
  • Fast Track, Breakthrough Therapy, Accelerated Approval, the 505(b)(2) pathway
• Regulatory exclusivity applications
  • Orphan drug, Rare Pediatric Disease Designation (RPDD) and Voucher (RPDV), Qualified Infectious Disease Product (QIDP) designation
• Representation at meetings
  • Pre-IND, IND, End of Phase I, End of Phase II, and Pre-NDA meetings
• Special protocol assessments
• Gap analysis and diligence assistance
• Supplement clinical, CMC, nonclinical, and regulatory capabilities