Large Scale Industry
EU GMP, cGMP, 21 CFR Part 11, EN ISO 13485, EN ISO 9001 compliance and 21 CFR Part 210/211 and 820ff. requirements are standard requests not only for large scale industry. But the large scale industry specially needs a professional and experienced service provider. Valicare GmbH as a competent consulting partner assures compliance to the regulatory and individual requirements.
Professional and international experienced project managers and flexible engineer teams perform qualification and validation support for complex projects and lines on a very high level. Aseptic filling, isolator systems, inspection technology, huge biotechnological and pharmaceutical production lines are daily challenges for our engineers. Validation of processes, cleaning procedure and analytical methods as well as design reviews and regulatory “due diligences” are regularly on their task list.
In cooperation with Syntegon Packaging Technology GmbH, our mother company, we have hands-on experiences and access to a broad spectrum of pharmaceutical standard technologies. If needed we make demands on the organizational support and assistance of the world-wide distributed Syntegon organization.
Contact us if you have any questions. We will gladly answer and advise you.