Methods validation

The Analytical Department provides comprehensive services of analytical methods through their:
• creation
• optimization
• validation
• transfer

We offer the development of complete analytical documentation in the form of Analytical Manual and Specifications, and preparation of registration documents in CTD format.

We have experience in the following chromatography techniques: UHPLC-MS/MS, HPLC-UV-VIS, HPLC-UV-DAD, HPLC-RID, HPLC-FLD and HS-GC-FID.

Validation of methods carried out in accordance with the guidelines:
- ICH (International Conference of Harmonisation)
- EMA (European Medicines Agency)
- FDA (Food and Drug Administration)
- European Pharmacopoeia (Ph. Eur. 7.0)
- Polish Pharmacopoeia (FP 8.0)