QUALITY ASSURANCE SERVICES
Medfiles offers you batch certification services in releasing medicinal products for sale in the EU. Our Qualified Persons (QPs) and support teams are experienced and have extensive knowledge of the pharmaceutical industry.
Pharmaceutical products imported from the so-called third countries are re-analysed in our laboratory and our QPs can certify batches before they are released to the EU market. Our licence also covers also manufacturing and certification of investigational medicinal products (IMPs).
We offer you consultation to improve your both 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 licensed pharmacists can act as responsible pharmacists of pharmaceutical wholesale in Finland, including short-time assignments.
Batch certification for IMP and commercial batches.
We help and consult in the establishment and/or implementation of quality management systems including GCP, GVP, GMP and medical device. We also offer GxP training and consultation, as well as assistance in SOP and quality instructions writing.
Our experienced auditors can offer:
- GCP site and vendor audits
- CRA audits
- Pharmacovigilance audits
- MD quality management system pre-audits
- GMP laboratory audits
For more information please contact
QA Director, QP