Omni Early Development Services
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                                    Strategy & Representation

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
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  • Home
  • Drug Development
    • Pre-clinical
    • CMC
    • Clinical
  • Regulatory
    • Strategy & Representation
    • Operations
    • Submissions
  • Medical Writing
    • Regulatory & Clinical
    • Scientific Grant
    • Scientific Manuscript