Regulatory affairs of human and veterinary medicines

Medfiles offers regulatory services in the Nordic countries and the Baltic countries, and through our regulatory network also in the majority of European countries. We have expertise in human and veterinary medicinal products, sterile and non-sterile products and biopharmaceuticals. Our personnel undergo continuous training to ensure that you receive services of the highest quality.

Services

  • Marketing authorisation applications
    • • Preparation and management of applications
    • • Coordination of processes (MRP, DCP, NP, CP)
    • • Evaluation of marketing authorisation dossiers
    • • Rx to OTC switches
    • • Preparation of OTC applications
    • • Market Access services
         › Health economics / Market access
    • • Regulatory strategy & management of drug development
        › Product development
    • • Acting as applicant and MAH for human and/or veterinary medicinal products

  • Maintenance of marketing authorisations
    • • Renewals
    • • Variations
    • • Notifications
    • • Handling of additional questions from authorities

  • eSubmission
    • • Compilation of eCTD, NeeS and VNeeS
    • • Submission by CESP

  • Product information texts (SmPC, PL, labelling)
    • • Writing
    • • Translations
    • • Package leaflet user tests and bridging reports
    • • Proof-reading of mock-ups
    • • Updates of local electronic product information texts
    • • Coordination of texts for centralized procedure (linguistic review)

  • Review of marketing material from the regulatory point of view

  • Consultation and training tailored to customer needs
    Examples of possible topics
  • regulanet® network
    • • Co-operation covers over 90 countries
    • • Local marketing authorisation tasks & pharmacovigilance
    • • Evaluation of local regulations / practices / authorities’ opinions


For more information please contact

Director, Healthcare Services Satu Kujala