Our consultants support you in developing GMP-compliant processes and in revceiving the manufacturing license according to § 13 of the AMG.
“Start ups”, small companies and minor medium-sized enterprises, pharmacies, clinical facilities for patient care, university hospitals and institutions do have special requirements on their process implementation.
The Valicare GmbH offers specialized project and consulting services for this life science level since the company has been founded 15 years ago.
An enjoyable number of such companies and organizations have already developed GMP-compliant processes in cooperation with Valicare GmbH and 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 the innovation and state-of-the-art of science and technology. We place the safety profile of your products, define specifications as usual for the product and the market, generate SOP systems and master batch records, qualify your equipment even if unusual and validate novel processes.
Valicare GmbH has a special focus on support of ATMP („Advanced Therapy Medicinal Product“) manufacturing processes, clinical trials or accreditation projects. Beyond that we are specialized on supporting the medical device and in vitro diagnostica producing industry.
Contact us if you have any questions. We will gladly answer and advise you.