API Support Services

At any development stage and scale of synthesis our services for contracted customers include all supporting activities that are required to be adequately cGMP compliant such as:

Our facilities support customers with on-site regulatory affairs personnel for the documentation of CMC development projects in the CTD format for convenient inclusion in IND / IMPD / NDA / MAA filing dossiers.

Support Services for Our Contracted Customers

Successful commercialization of a regulated pharmaceutical product is directly related to full compliance with cGMP rules, requiring a high level of analytical, validation and regulatory support. Inthera PharmaMed stands above the competition with trained professionals who adhere to the highest possible regulatory standards at all stages of product development.

Analytical Support

Throughout the whole development and industrial lifecycle of all of our APIs we provide analytical support for contracted customers as required to be cGMP compliant.

All API batches are released by independent Quality Control departments. Analytical methods are developed and validated in accordance with ICH guidelines, not only applying to release test methods, but also to In-Process Controls and test methods used in cleaning validation. Stability studies are conducted, including forced degradation studies as well as investigational and formal ICH stability studies.

For all Active Pharmaceutical Ingredients (APIs) structures are proven through instrumental analyses including NMR, LC-MS, GC-MS and X-ray structural analysis. The respective analytical reference standards are prepared and analytically characterized. As required by ICH guidelines, API impurities like side products or degradants are identified through instrumental analysis and reference samples thereof are synthesized.

Validation Support

At all sites validations of all cGMP relevant systems are conducted as required to be cGMP compliant, from risk analysis and execution right through to evaluation and validation reporting of:

All relevant production / analytical equipment is qualified according to cGMP requirements