News from Valicare

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Valicare GmbH celebrates its 15th anniversary, 14th of November 2017.

Founded in 2002 in Frankfurt am Main, Valicare GmbH is a wholly-owned subsidiary of the Robert Bosch Packaging GmbH (BU Pharma) and offers a wide range of quality services to the Good Manufacturing Practices (GMP) regulated industry. In 2006, Valicare s.r.o. was founded in Trencin (Slovakia) as a joint venture between Valicare GmbH and Heitec AG . Valicare GmbH is ISO 9001-certified since 2011 and has 72 employees with a wide range of engineering and academic backgrounds.

Valicare offers services for the pharma, biotechnology, medical device and advanced therapy medicinal product (ATMP) industry. Our support covers the conception, consulting and implementation of GMP- and ISO-compliant systems and processes. Experienced project teams and certified auditors work on risk-based qualification & validation of equipment and processes as well as on audit & inspection projects.

ATMPs are served by scientists with many years of experience in development and manufacturing of those special products. They are very familiar with the actual directives of ATMPs and support their customers in developing GMP-compliant production processes and receiving the manufacturing license in accordance with §13 of the German Pharmaceutical Law (AMG).

Medical technology engineers experienced in development processes, quality management and regulatory affairs support the medical device industry with a broad level of services.

The Valicare teams placed in Frankfurt/Main, Crailsheim, Waiblingen and Trencin (Slovakia) look back on 15 years of GMP-compliant operative and consulting project business. A period in which more than 2000 projects were executed successfully.

Based on this treasure trove of experience and supplemented trough regular GMP compliance trainings our employees offer services at a high professional level always in compliance with regulatory requirements.

The management of Valicare GmbH, represented by the managing director Dr. Berthold Düthorn and the authorized officer Dr. Malke Lütgens, used the anniversary as an opportunity to invite all Valicare EU employees to a two-day strategy seminar in Oestrich-Winkel, Rheingau. The colleagues of the Slovakian subsidiary, VCSK, were represented by managing director Martin Gerlich and a senior project manager. Together all reviewed the successful past and presented forward-looking concepts and strategies.

The jubilee was celebrated extensively during sightseeing and wine tasting at the very impressive “Kloster Eberbach” followed by a ceremonial dinner in a traditional restaurant at Oestrich-Winkel.

All participants look forward to the next 15 successful years.

 

Further information


 
Dr Claudia Papewalis is giving a GMP for ATMP training

GMP for ATMPs

If you want to know more about the regulatory requirements requested for manufacturing ATMPs, contact our experts or take part at one of our internal GMP training courses.

A scientist is looking at t-cells visible at a computer screen

GMP-compliant manufacturing process

Valicare supports start-ups like polybiocept in transferring cell-culturing methods developed at the laboratory into a GMP-compliant manufacturing process. Check the press release and get an overview about our GMP for ATMP services.

cell culture, ATMPs

„Guidelines on Good Manufacturing Practice (GMP) specific to Advanced Therapy Medicinal Products”

On 22th of November 2017 the European Commission adopted the "Guidelines on Good Manufacturing Practices (GMP) specific to Advanced Therapy Medicinal Products".