Reg CMC support

CMC Regulatory Services

CMC Documentation

  • Preparation, review and compilation of CMC documents for clinical trial applications (IMPD, IND)
  • Preparation, review and compilation of CMC documents for marketing authorization applications (NDA, ANDA, MAA, renewals)
  • Preparation, review and compilation of DMFs, including assessment of third party API supplier DMFs
Discuss Your Documentation Needs
CMC Documentation
Compliance

Regulatory Compliance & Gap Analysis

  • Compliance review of CMC documentation for accuracy, completeness, suitability and acceptability
  • Gap analyses and recommendations to strengthen dossier compliance
  • Anticipation of potential Health Authority questions and preparation of mitigation strategies
Request a Compliance Review

Change Control & Lifecycle Support

  • Regulatory impact assessments for proposed changes in manufacturing, packaging, distribution and analytical testing
  • Preparation, review and compilation of CMC variation packages and Annual Reports
  • Development of regulatory strategies for proposed CMC changes or variations
Plan Your Lifecycle Strategy
Chemistry
Health Authority Interactions

Health Authority Interactions

  • Preparation of responses to Health Authority questions worldwide
  • Coordination of the full HA response process (planning, coordination, submission)
  • Generation, coordination, review and finalization of procedures, study protocols and reports to meet HA commitments
Support with HA Questions
REG CMC Support

Additional Support

  • Guidance on issues impacting CMC dossiers
  • Training and onboarding of new RA CMC professionals
Request Additional Support

Vorstenbosch Regulatory CMC Support
St. Lambertusweg 83A
5291 AA Gemonde
The Netherlands
Email: bertine@regcmcsupport.com
Phone: +31 (0)6 23207407