We offer you consultation to improve your quality management and quality-related processes. Medfiles quality unit has expertise in quality management systems of clinical trials (GCP), pharmacovigilance (GVP), good manufacturing practice (GMP) and medical devices.

In addition, we offer you GDP compliant expertise and extensive knowledge of pharmaceutical wholesale activities. Our legalised pharmacists can act as responsible pharmacists of pharmaceutical wholesale in Finland, including short-time assignments.

QP services

  • Batch certification in compliance with EU GMP guidelines for
    • non-sterile human and veterinary medicinal products and
    • investigational products
  • Audits
  • Technical and quality agreements
  • Product quality reviews

Quality services

  • Clinical trials (GCP)
    • Assistance in establishment and implementation of quality assurance system
    • Study documentation, site audits and pre-inspections
    • Vendor and CRA audits
    • GCP training and consultation
    • SOP writing, review and consultation
  • Pharmacovigilance (GVP)
    • Pharmacovigilance audits
    • GVP training and consultation
    • SOP writing, review and consultation
  • Medical devices
    • Consultation on requirements, establishment and implementation of quality management system
    • Quality management system pre-audits
    • Outsourced quality manager or expert
    • Vendor and supplier audits
    • SOP writing, review and consultation
  • Good manufacturing practice (GMP)
    • GMP laboratory audits and consultation
    • GMP training and consultation
    • SOP writing, review and consultation

Distribution practices:
Pharmaceutical wholesale services and product complaints

  • Responsible pharmacists in Finland
  • Wholesale licence applications
  • Preparation and update of SOPs
  • GDP audits
  • GDP training and consultation
  • Consultation services
    • Import and logistics
    • Narcotics control and mandatory reserve supplies
    • Management of product complaints