EU Batch Certification and Release
We perform Quality Control and EU Batch Release both for medicinal products imported from outside the European Union (EU) and those batches undergo packaging in house.
Delivery to customers (patients) takes place only after our Qualified Person (QP) has certified every production batch that has been produced and controlled in accordance with the relevant country legal requirements and any other regulations relevant to the production, control and release of medicinal products.
Performing analyses of pharmaceutical finished products and raw materials. During the investigations special attention is paid to product safety, drug stability and retesting of pharmaceutical products from third countries.
- Analyses are performed according to the analytical testing procedures
- Certificate of Analysis
- Stability studies
- Validation of analytical methods