Pharmaceutical Solutions holds a Manufacturer’s Authorisation (IMP12623/00001) allowing the site to certify batches of Human Investigational Medicinal Products for clinical trials operating in the EU.

Pharmaceutical Solutions are licensed to certify, or import and certify, batches of the following dosage forms:

• Batch Certification:
  • Sterile Products
  • Non-sterile Products
  • Biological medicinal products
    • Biotechnology Products
    • Human or Animal Extracted Products
       
• Importation
  • Sterile products
    • Aseptically prepared
    • Terminally sterilised
  • Non-sterile products
  • Biological medicinal products
    • Biotechnology Products
    • Human or Animal Extracted Products

Certification and Importation of medicinal products is the end point of a process that gathers and assesses all of the information related to the product and the trial in order to provide the Qualified Person with confidence to certify the product. Pharmaceutical Solutions also provides this service, including an assessment of the product supply chain through audits.

Please contact us if you are interested in discussing Pharmaceutical Solutions' EU importation and/or certification services.

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