We advise and support you in the development of GMP-compliant processes for the production of cell or tissue preparations, also in cooperation with the MHH Presidium's Office for Quality Management in Clinical Research.
We offer extensive training courses and seminars in the area of GMP and quality management.
After agreeing on a delimitation of responsibilities and appropriate training, we offer supervised access to our clean rooms.
We offer advice and practical support when applying for permits in accordance with §§4a and 21a AMG, in particular when creating module 3 of the CTD (Common Technical Document) and test plans - IMPD (Investigational Medicinal Product Dossier; also in cooperation with the MHH) -The Presidium's Office for Quality Management in Clinical Research.
We prepare expert reports or support you in creating them for all the topics listed and also for monographs that conform to the pharmaceutical register.