Quality is reflected in everything we do at Syntagon. Our main facility in Södertälje, Sweden operates under full Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) compliance in accordance to the International Congress on Harmonization (ICH) guidelines.
Our organizational set-up, documentation, equipment, procedures, processes and people are all aligned to ensure that your API meets the agreed specifications for strength, purity and identity. For you, this means speedy regulatory approval for clinical trials, and the confidence of passing the due diligence process of even the most critical partner.
We are audited regularly by the Swedish Medical Agency and are fully compliant in the preparation of clinical APIs in accordance with regulatory guidelines (EMEA/FDA). In addition to this, we host many audits from customers throughout Europe and North America.