CMC expert services

Medfiles offers a diverse range of expertise for your pharmaceutical chemical documentation needs. We have a team of professionals who undergo continuous training to stay abreast of 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.

CMC documentation

  • 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
  • Consultation and training

Project management and Technology transfer services

Our experts have a long working history in both analytical chemistry and manufacturing processes. Our skilled resources can help you with both short-term and long-term projects.

Medfiles’ team has provided CMC expertise in several development and technology transfer projects.

CMC EXPERTISE

  • Outsourcing experts to projects
  • Our competence covers manufacturing processes as well as analytical tasks

PROJECT COORDINATION

  • Compenent coordination of technolgy transfer tasks while ensuring regulatory compliance

REGULATORY APPROVAL

  • Compilation of full quality documention needed needed for a succesful requlatory approval of your technology transfer

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