PHARMACEUTICAL-CHEMICAL (CMC) EXPERT SERVICES AND CMC CONSULTING
Understanding the requirements for chemistry, manufacturing and controls (CMC), contributes to the fastest possible access of the medicinal product to patients. We support you with expert CMC consulting and documentation services that align with current regulatory expectations (small molecules). Our competent team of experts consults during product development and writes marketing authorisation documentation helping to avoid unnecessary delays and ensuring submission readiness.
Medfiles CMC team has years of experience in sterile and non-sterile human and veterinary products as well as solid competence in consultancy services in regulatory and transfer strategies. Whether you’re preparing a new marketing authorisation application or submitting a variation, we handle the CMC documentation for you – ready for submission to both European pharmaceutical authorities and the US FDA. Our experience covers both human and veterinary products.
The CMC team combines deep industry knowledge with regulatory insight, gained through years of work with both pharmaceutical companies and authorities. We stay up to date with evolving guidelines through continuous training, so you can be confident your documentation meets the latest requirements. Our CMC service comes with guaranteed back-ups for our experts, regardless of the duration of the project.
Our expertise ensures that your dossier will meet the current regulatory requirements with a reasonable level of detail, aiming for a positive outcome as well as easy maintenance of the marketing authorisation in the future. Medfiles’ CMC consulting and CMC documentation services are tailored to each client’s needs and can be seamlessly integrated into broader projects including, clinical, medical device or pharmacovigilance services.
6 CMC experts with avg. 19 years of experience
Medfiles’ CMC experts support regulatory compliance and help minimise the risk of delays later in development. By involving us early on, you streamline your development process and secure high-quality submissions for your marketing authorisation.
CMC documentation service covers the following areas
- Marketing authorisation applications
- documentation for module 3 or Part II
- quality overall summaries
- requests for additional information during marketing authorisation procedures
- evaluation of dossiers (gap analysis)
- Variation applications
- consultation and classification of variations
- preparation of documentation
- Clinical trial application documentation (IMPD, IND)
- Active substance documentation (ASMF, DMF and CEP)
- Validation plans and reports
- Risk assessments (nitrosamines, elemental impurities)
- Consultation and training
See also:
- How to write a strong Module 3 for a marketing authorisation application
- Q&A: What makes a strong Module 3 quality dossier
- The new EC variation guideline – what’s new?
- Repurposing human medicines for veterinary use: key considerations
- Changes to EU variations coming in 2025
PROJECT MANAGEMENT, DRUG DEVELOPMENT AND TECHNOLOGY TRANSFERS
Our CMC team combines solid experience in analytical chemistry and pharmaceutical manufacturing. This helps us understand our clients’ needs and the practical challenges they deal with in their daily work. We have successfully assisted our clients with numerous development projects and technology transfers ensuring smooth transitions and regulatory compliance. Our CMC experts are experienced in coordinating analytical method transfers and consulting in analytical chemistry.
These services include:
- outsourced experts for your projects – for both manufacturing processes and analytics
- competent coordination of technology transfers, taking into account the regulatory requirements
- compilation of quality documentation to support smooth regulatory approval of technology transfers.
By choosing Medfiles, you gain the flexibility to outsource all or part of your project to us. You benefit from dedicated experts, regulatory insight, and tailored solutions to support the successful development and approval of your products. Our pricing is typically based on actual hours worked, with clear preliminary estimates provided before the work begins to give you confidence in planning and budgeting.
“Medfiles’ expert provided us invaluable support in solving an analytical problem. Thank you for your hard work – it really exceeded our expectations!”
– Client feedback
“In particular, Medfiles’ very strong CMC expertise has been helpful in performing gap evaluation on existing files, addressing gaps, and preparing updated and upgraded dossiers for submissions in Europe.”
– Bimeda
“With special expertise in the manufacturing of injection products, Medfiles has helped us in preparing documentation for maintaining a marketing authorisation in the United States.”
– Vetcare
News and insights on CMC
Our expert team regularly writes blogs on CMC, including tips for analytical method transfers and pharmaceutical technology transfer.
Contact us
You may also be interested in:
- How to write a strong Module 3 for a marketing authorisation application
- Q&A: What makes a strong Module 3 quality dossier
- The new EC variation guideline – what’s new?
- Repurposing human medicines for veterinary use: key considerations
- How companies developing human and veterinary medicines can benefit from SME status in the EU
- Changes to EU variations coming in 2025
- Guide: How to perform pharmaceutical technology transfer?
- Best practices for analytical method transfers
- Bimeda & Medfiles: Partnership in veterinary regulatory affairs in the EU
- Vetcare & Medfiles: Working together on the maintenance of marketing authorisations and pharmacovigilance of veterinary medicines
- Six reasons to engage CMC experts in drug development
- Pharmaceutical Chemical (CMC) Expert’s journey at Medfiles
- Guide: Storage conditions for pharmaceuticals