Project management for all stages of new product development through FDA approval
Pre-clinical development regulatory support
- Regulatory review strategy including evaluation of the best FDA filing pathway
Active and inactive ingredient source review and evaluation of compliance to regulated markets - DMF evaluation
- LOA request and compilation
- Pre-IND and IND strategy, preparation, and submission for NDA 505(b)(2) products; investigator brochure
- CMC gap analysis and remediation strategy
- Genotoxic impurities risk assessment and strategy
- Nitrosamine assessment
- Preparation, compilation, and review of all eCTD Modules
- Complete ANDA regulatory support including writing, review, compilation, publishing and filing
- Controlled correspondence preparation and submission
- Inactive ingredient levels
- Q1/Q2 for ANDAs
- Reference product selections for NDA 505(b)(2) and ANDAs
- Regulatory strategy related controlled correspondences
- Solicit bids from clinical regulatory experts, CROs toxicological assessment experts, clinical packaging companies
- Review data and reports
- Evaluate dossiers and batch records and validation reports for tech transfers and perform gap analysis
- Providing site transfer strategies including SUPAC review
Phone
Location
6655 Amberton Drive,
Unit O, Elkridge, MD 21075