GMP-compliant processes and manufacturing license according to AMG § 13

Our experienced project managers support you in adoption your processes to GMP and accompany you on the journey to your manufacturing license acc. to AMG § 13.

Start-ups, small companies and minor medium-sized enterprises, pharmacies, point of care facilities, university hospitals, and institutions have special requirements to processes and their implementation.

Valicare has been catering to life science by offering specialized project and consulting services for more than over two decades.

We are proud to look back on a track-record of multitude successful cooperation projects with customers adopting GMP-compliant processes and achieving their goal of obtaining a 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 help carving out the safety profile for your products, define state-of-the-art specifications, establish SOP systems and support master batch records writing, qualify your equipment, and contribute to validation of your novel process.

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. 

Contact us if you have any questions. We will gladly answer and advise you.