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CMC Support

Our CMC support functions include:

Regulatory CMC Services – Small and Large Molecules/Vaccines:

  • Strategic drug development, support and guidance
  • Authoring, review and/or compilation of CMC CTD sections for initial INDs, IMPDs, CTAs, 505(b)2, NDAs, ANDAs, BLAs, MAAs
  • Follow-on ROW initial registrations
  • Post-approval supplements, variations and other lifecycle maintenance submissions (Annual Reports, Renewals, etc.)
  • Gap analysis, mitigation and remediation
  • DMF authoring, compilation, review and acting as confidential DMF liaison
  • Other CMC compliance and technical writing activities

Health Authority Communications, Meetings and Other Interactions:

  • Support of FDA and other Health Authority (HA) meetings (INTERACT, pre-IND, EOP2, pre-NDA/BLA, Scientific Advice, etc.) across all disciplines (CMC, Clinical, Nonclinical)
  • Negotiations to facilitate CMC approvals
  • Responses to review questions (RFIs, Queries), ad-hoc inquiries
  • Preparation of briefing books/background packages
  • Support of scientific advice meetings and company preparation for HA meetings
  • Monitoring/tracking of commitments
  • Act as a US Agent
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