CMC Regulatory Affairs

BRC recommends and manages strategic path options for CMC-related development to support regulatory programs for drug product candidates, including services that include, among others:
  • Expert CMC regulatory consultation on lifecyle drug development.
  • Consultation and interface on FDA inquiries on CMC regulatory issues.
  • Draft, edit, and compile all regulatory CMC submissions and responses to regulatory agency questions.
  • Guidance and documentation to meet regulatory needs consistent with harmonized manufacturing standards.
  • Consults on audits and investigations of manufacturing facilities in support of drug development activities.

The BRC Difference

  • ​Expert technical specialists for CMC-related drug development issues.
  • Timeline management to link stable API and formulation materials to study start-up.
  • Expert teams for qualifying CMC vendors and quickly addressing potential hurdles affecting in API and formulation development.
  • Quality control of final CMC-related reports.
  • Technical studies and final reports compliant with FDA and ICH standards and guidelines.

CMC Regulatory Services

Management Approach
  • Compliance with FDA & ICH standards (e.g., product quality & reports).
  • Competitive bidding process for component pricing.
  • CMC/Manufacturing Timeline integrated to the overall drug development plan.
  • Proprietary project management process for client updates.

CMC Development & Regulatory Services
  • Agency-compliant CMC Technical Reports.
  • Quality Target Product Profile (QTPP).
  • Chemical Profile.
  • Analytical Methods Validation.
  • Impurities Assay and Report.
  • ​API synthesis and associated stability profile.
  • Nonclinical test formulations (GLP or GMP) and vehicle control, with associated stability and validated protocols & analytical methods.
  • Clinical test formulations (GMP) and matching placebo with associated pre- and in-study stability, with validated protocols & analytical methods. 
  • Agency-compliant labeling.
  • Tech transfer for manufacturing scale-up.
  • Among other deliverables tailored to preclincial and clinical development needs.