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Home  Our Services  Regulatory and Safety Services  Pharmaceutical documentation

Pharmaceutical documentation

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.

<img src="man.jpg" alt="medfiles' expert discussing pharmaceutical documentation over phone">

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

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  • Regulatory and Safety Services
    • Regulatory affairs of human and veterinary medicines
    • Pharmaceutical documentation
    • Medical devices and IVDs
    • Food & Nutrition and Feed
    • QP, quality and distribution practices
    • Translation services
    • Health economics and market access services
    • Pharmacovigilance Services for Human and Veterinary Medicines

For more information please contact

Ulla Orava
Ulla Orava

Manager of Pharmaceutical Chemical Operations
expert@medfiles.eu
Mobile +358 40 577 7698

R&D / Laboratory services

Clinical Research Services

Regulatory and Safety Services

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  • R&D / Laboratory services
    • Analytical services
    • Microbiological services
    • Product development and production of IMPs
    • QP, quality and distribution practices
  • Clinical Research Services
    • Clinical study services
    • Medical devices and IVDs
    • Food & Nutrition and Feed
    • QP, quality and distribution practices
    • Pharmacovigilance Services for Human and Veterinary Medicines
  • Regulatory and Safety Services
    • Regulatory affairs of human and veterinary medicines
    • Pharmaceutical documentation
    • Medical devices and IVDs
    • Food & Nutrition and Feed
    • QP, quality and distribution practices
    • Translation services
    • Health economics and market access services
    • Pharmacovigilance Services for Human and Veterinary Medicines

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Volttikatu 5, FI-70700 Kuopio, FINLAND | Tel. +358 20 7446 800

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