Chemistry, Manufacturing and Controls (CMC)

  • Strategic planning and definition of regulatory requirements consistent with ICH, SUPAC and CTD Guidances
  • Regulatory advice including consulting with FDA anonymously or on your behalf
  • Training on FDA, ICH and CTD guidelines and company SOPs
  • Meetings with Regulatory Authorities: Planning, preparation and follow-up
  • Document review: Draft reports, data, and regulatory submissions
  • Document preparation: INDs, NDAs, ANDAs, CTDs, supplements, responses to questions, and validation reports
  • Old products: Evaluation versus NDA; strategic planning; discussions with FDA; NDA amendments and supplements
  • Drug Master Files (DMF)

Quality Assurance and Compliance

  • SOPs: Evaluation, revision, writing, and training
  • 483s/Warning Letters: Response strategy and preparation; implementation of quality improvement program
  • Analytical Laboratory: GMP audits; preparations for inspection; efficiency evaluations; analyst GMP and SOP training
  • Quality Agreements with contract laboratories and manufacturing sites
  • Product Annual Reviews