Regulatory Communication; Technical Writing

Mark Staples has broad experience as compiler, author and reviewer of the Chemistry, Manufacturing and Controls (CMC or equivalent) section of regulatory submissions.

CUSP tailors services to ensure written materials for regulatory communication are produced as cost-efficiently and expeditiously as possible considering the requirements of the submission-

  1. Supporting documents: Development work plans and reports; method transfer, analytical and stability protocols; validation reports; batch records

  2. Regulatory communications and submissions: CMC  (or equivalent) section of regulatory submissions, generally in Common Technical Document (CTD) or electronic CTD (eCTD) formats

  3. Briefing documents (pre-IND meetings)

  4. Annual Reports

  5. Investigational New Drug Applications (INDs)

  6. New Drug Applications (NDAs)

  7. Marketing Authorization Applications (MAAs)

  8. Investigational Medicinal Product Dossiers (IMPDs)

  9. Audit services: Provide technical support for audit of facilities, documents and processes for Good Manufacturing Practice (GMP) manufacturing of clinical and commercial supplies

  10. Other (not targeted for regulatory agency review): Write technical sections for presentations to investors and Boards involving development of drugs, biologics, or combination products; provide due diligence evaluation of technologies for potential investments; provide technology assessment for patent review.