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
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6655 Amberton Drive,
Unit O, ​Elkridge, MD 21075