Advanced Therapy Medicinal Products
ATMPs represent an innovative group of drugs that is gaining increasing importance. ATMPs have been classified as medicinal products and must therefore be compliant with the EU requirements. Many of these products are developed and manufactured at universities, hospitals and in small and medium-sized enterprises. This leads to particular challenges in complying with approval requirements, not only for manufacturers, but also for approval and regulatory authorities. Since 2017, there has been a special GMP guideline for ATMPs in order to meet the particularities of manufacturing ATMPs.
We are specialized for validated testing procedures for the GMP compliant quality control of ATMPs (starting material, intermediate products and the final product).
We support you in all questions of quality control in the context of your ATMP production.