GMP-compliant processes and manufacturing license according to AMG § 13
Our experienced project managers support you in developing your GMP processes and accompany you on the journey to your manufacturing license acc. to AMG § 13.
Start-ups, small companies and minor medium-sized enterprises, pharmacies, clinical facilities for patient care, university hospitals, and institutions have special requirements regarding their process implementation.
Valicare has already been offering specialized project and consulting services for this life science level for 22 years.
We are proud to say that a considerable number of such companies and organizations have already developed GMP-compliant processes in cooperation with Valicare and have received their manufacturing license in accordance with § 13 of the German Pharmaceutical Law (AMG). Our consultants are well versed in understanding pharmaceutical and biopharmaceutical processes at the interface of innovation and state-of-the-art science and technology. We place the safety profile of your products, define specifications for the product and market, generate SOP systems and master batch records, qualify your equipment, and validate novel processes.
Valicare has a special focus on support of manufacturing processes, clinical trials, and accreditation projects of advanced therapy medicinal products (ATMPs), such as gene therapies, cell therapies and biotechnologically processed tissue products. We also specialize in supporting companies producing medical devices and in vitro diagnostics.
Contact us if you have any questions. We will gladly answer and advise you.
