QP, quality and distribution practices

We have Qualified Persons (QPs) with extensive knowledge about the pharmaceutical industry and experienced support teams ready to assist you in releasing medicinal products for sale in the EU.  We also re-analyse pharmaceutical products imported from the 3rd countries, and our QPs can certify batches before they are released into the EU market.

We offer you the services of experienced quality experts who handle tasks related to quality management and help you shape up your quality-related processes. We have expertise in quality management systems of clinical trials (GCP), pharmacovigilance (GVP), good manufacturing practice (GMP), and medical devices.

In addition, we offer you expertise and extensive knowledge of pharmaceutical wholesale activities. We can act as a Responsible Pharmacist and, if needed, handle the entire product complaint process.

QP services

  • • Batch certification in compliance with EU GMP guidelines
  • • EU release for non-sterile human/veterinary medicinal products and investigational products
  • • Review of manufacturing and testing records in compliance with EU GMP guidelines, product specifications and marketing authorisation
  • • Audits
  • • Technical agreements
  • • Complaints
  • • Product quality reviews
  • • Support services for changing the batch release site

Quality services

  • Clinical trials (GCP)
    • • Assistance in establishment and implementation of quality assurance system
    • • Study documentation audits, e.g.
      • • Protocol
      • • Subject information and informed consent
      • • Case report forms (CRF)
      • • Study files
      • • Reports
    • • Study site audits / pre-inspections
    • • Vendor audits
    • • Compliance visits
    • • GCP training and consultation
    • • SOP writing, review and consultation
       
  • Pharmacovigilance (GVP)
    • • Pharmacovigilance audits
    • • GVP training and consultation
    • • SOP writing, review and consultation
       
  • Good manufacturing practice (GMP)
    • • GMP laboratory audits and consultation
    • • GMP 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
    • • Vendor and supplier audits
    • • SOP writing, review and consultation
       

Distribution practices: Pharmaceutical Wholesaling Services and Product Complaints

  • • Responsible pharmacists in Finland
  • • Wholesale license applications
  • • Preparation and updating of standard operating procedures
  • • GDP audits
  • • GDP training
  • • Import and logistics issues
  • • Obligatory storage issues
  • • Management of product complaints