CMC & REGULATORY DOCUMENTATION
CMC & REGULATORY SUPPORT THROUGHOUT THE PRODUCT LIFECYCLE
PHA FARMED provides comprehensive CMC and regulatory documentation support throughout the pharmaceutical product lifecycle, from development and regulatory submissions to post-approval activities.
Our senior experts support clients with the preparation, review and lifecycle management of high-quality CMC documentation, ensuring alignment with EU and UK regulatory requirements and applicable international guidelines.
CMC DEVELOPMENT & DOCUMENTATION
CMC support throughout pharmaceutical development and regulatory submission.
- CMC development strategy
- Quality documentation preparation and review
- CTD Module 3 preparation and lifecycle management
- Drug substance and drug product documentation
- Manufacturing process documentation
- Specifications and analytical documentation
- Stability documentation and shelf-life support
REGULATORY SUBMISSIONS & LIFECYCLE MANAGEMENT
Regulatory documentation support from initial submission through post-approval activities.
- Marketing Authorisation Application (MAA) support
- CMC documentation for EU & UK submissions
- Responses to regulatory authority questions
- Variations and post-approval changes
- Renewals and lifecycle maintenance
- Regulatory gap assessments
- Coordination of documentation across project partners
TECHNICAL & SCIENTIFIC SUPPORT
Senior-level scientific and technical support tailored to the product and development stage.
- Technical documentation review
- CMC gap analysis
- Analytical and stability strategy support
- Manufacturing and technology-transfer support
- Product development documentation
- Due diligence and technical assessments
- Coordination with manufacturers, laboratories and other specialised partners
Need support with CMC or regulatory documentation?
Let’s discuss how PHA FARMED can support your CMC development, regulatory documentation and lifecycle management needs.