The regulatory requirements fo ATMPs are well known by Valicare experts
ATMP, the shortcut for “advanced therapy medicinal product”, stands for revolutionary innovations in medical treatment. The market for these novel therapeutics is strongly increasing.They are defined through the guideline 2003/63/EG and comprise gene therapy, somatic cell therapy and tissue engineering.
ATMPs have a big potential for treatment of cancers, metabolic, viral and autoimmune diseases and the expectations are very high that they will be effective where conventional approaches fail. The production of ATMPs is controlled by pharmaceutical law (AMG), the EU GMP guideline and special directives.
We work on GMP requirements for drug manufacturing for over 15 years now. Meanwhile we can offer you an extensive GMP service portfolio. But ATMPs need also special product-specific GMP solutions. Some of our GMP consultants are highly specialized in ATMPs and they are also very close to research and development.
They know the actual directives for ATMPs very well and can support you with technical and scientific expertise on the highest level. We are pleased to accompany you on the way to the GMP-compliant production of your ATMP.