In addition to the usual analytical methods required for in-process control and analyses of the final bulk peptide, Peptisyntha has in-house experts and day-to-day access to state-of-the-art analytical techniques such as LC-MS, ICP-MS, FAB-MS, multi-nuclear 500 Mhz NMR, capillary electrophoresis and ion chromatography.

A dedicated QA/QC department guarantees fully cGMP compliant production, as well as testing and documentation standards in accordance with the strictest FDA and EMEA requirements.   Peptisyntha has developed and maintains a robust quality assurance system covering all aspects required for the cGMP production of  peptide API’s.   Large scale production facilities in Brussels, Belgium have been successfully inspected by the FDA.  Customers’ audits are held on demand.   Several customers have decided to reduce their own quality testing on bulk peptides supplied by Peptisyntha on account of their confidence in our quality procedures.

Continued regulatory assistance is provided by Peptisyntha throughout any project to make sure that our developments fit with the customers’ requirements.  This includes timely filing and updates of DMFs as required.