That's why we also take the selection of personnel very seriously. Our 15-member QU & RA competence team are all highly qualified and have scientific backgrounds. Our qualified person (AMG) is responsible for approving the import or placing MTMG active substances on the market, providing legal advice on quality agreements, and two exclusive QU consultants in China carry out audits of active substance manufacturers.

Our audit-profiled employees assist with inspections or carry out audits and so have a precise knowledge of the GMP status of our API manufacturers.

All employees have comprehensive specialist knowledge of CEP and ASMF approval documents and the life cycle management of approval documents.

For API manufacturers, we offer an eCTD service that also benefits our customers by providing you with the required approval documents in the required format.

For third country manufacturers, we can also act as an authorised representative for approvals (ASMF, CEP). Of course, our QU team and our quality system meet all requirements for active pharmaceutical ingredients (API) in accordance with the AMG/AMWHV/TAMG/EU GMP Part II/GDP regulations for API, human + veterinary.