High quality standards and writing skills are needed to ensure and maintain the quality, consistency and technical validity of the CTD Quality Module 3 (also called Chemistry, Manufacturing and Control (CMC) regulatory documentation), since the CMC regulatory documentation used to support chemical and pharmaceutical development and commercial manufacturing of Drug Substances and Drug Products will be assessed by Health Agencies (HA) worldwide.
To increase the efficiency and dossier compliance, a solid change control system needs to be incorporated in order to document scientifically/manufacturing driven activities or changes.
Bertine Vorstenbosch - de Wijs, a freelance RA CMC Specialist with extensive industrial and regulatory experience in Chemistry, Manufacturing and Control (CMC) of Drug Substances as well as Drug Products, can take care of the preparation, review and compilation of CMC regulatory documents throughout the entire lifecycle of your product.
- Vorstenbosch Regulatory Support offers international CMC* regulatory services in the fields of human and veterinary Drug Products covering all regulated markets (worldwide).
- Your company can rely on our CMC/change control expertise and high quality standards in CTD Quality Module 3 writing for any type of application.
- Our CMC regulatory services will release you from the CTD Quality Module
3 writing/preparation burden, and will give you more time and flexibility, so that you are able to focus on the core business activities required within your company!
CMC regulatory services
Vorstenbosch Regulatory Support can support you with the following CMC regulatory services:
- Preparation, review and compilation of CMC regulatory documents for clinical trial applications (e.g. IMPD, IND) and/or marketing authorization applications (e.g. NDA, ANDA, MAA, renewals).
- Preparation, review and compilation of DMFs, including assessment of DMFs from third party API suppliers.
- Review of CMC regulatory documents with respect to regulatory compliance by evaluating data for accuracy, completeness, suitability and acceptability (compliance check / gap analysis).
- Provision of recommendations to improve compliance and to anticipate on potential questions from Health Agencies (HA).
- Preparation of regulatory impact assessment on change control requests proposed in manufacturing, packaging, distribution and analytical testing of the drug substance as well as the drug product.
- Preparation, review and compilation of CMC variation documentation packages and Annual Reports.
- Preparation of proposals regarding RA strategy required for proposed CMC change control requests / variations.
- Preparation of answers to HA questions (worldwide) and coordination of the HA response process i.e. sees to planning, coordination and submission).
- Generation, coordination, review and finalisation of procedures, study protocols and reports to meet HA commitments.
- Provision of guidance and guidelines on issues impacting CMC dossiers.
- Assist with training of new RA CMC professionals.