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