Medfiles offers a diverse range of expertise for your pharmaceutical chemical documentation needs. We have a team of professionals who undergo continuous training and keep up with the latest guidelines. Our extensive work experience at regulatory authorities and in the pharmaceutical industry guarantees an efficient and high-quality service. Whether you need a new marketing authorisation or a single variation, you can leave the documentation work to us.
Services
- Marketing authorisation applications
- Module 3 or Part II documentation
- Quality Overall Summaries
- Requests for supplementary information
- Dossier evaluation (gap analysis)
- Variations
- Consultation and classification of variations
- Writing of documentation
- Renewals
- Documentation for clinical trial applications (IMPD, IND)
- ASMF, DMF and CEP documentation
- Validation protocols and reports
- Project management
- Consultation and training
