Headquarter in Frankfurt am Main, Germany
Valicare GmbH is an ISO 9001-certified GMP service company founded in 2002 in Frankfurt am Main.
The parent company is Syntegon Technology GmbH, a leading provider of plant and filling technology and strategic lifecycle management partner for the pharmaceutical and biotech industries.
The regulatory expertise of Valicare and the innovative and high-quality plant technology of Syntegon offer the customer holistic approaches and seamless processes.
Valicare also operates independently of manufacturers and advises and supports customers in GMP topics, qualification and validation.
Together with the site in Turňa, Slovakia, which was founded in 2006 as a joint venture between Valicare GmbH and Heitec AG, more than 120 employees, mainly engineers and scientists, work for Valicare.
Our customers are small, medium-sized and large companies in the pharmaceutical, biotechnology and medical device manufacturing industries. But we also support institutes or start-ups on the way to a GMP-compliant manufacturing license under §13 AMG for biological or biopharmaceutical products.
We support and accompany you in GMP and ISO compliance, quality management (GMP Compliance Management | Valicare GmbH | Valicare GmbH), in the planning and execution of risk-based qualification of plants, cleanrooms, equipment and the validation of GMP relevant processes and systems (GMP-Compliant Qualification & Validation | Valicare GmbH | Valicare GmbH).
Due to the special core competencies and experiences of our PhD scientists and senior consultants, we provide you with comprehensive support in the field of gene and cell therapy (Cell and Gene Therapeutics | Valicare GmbH | Valicare GmbH).
We work internationally in multidisciplinary teams, always oriented to the current state of the art and in compliance with the international regulations (FDA, GMP and (c)GMP, PIC/S, GAMP, DIN EN ISO, ICH), pharmacopoeias (EP, USP) as well as AMG and AMWHV.