Qualification and validation support for complex projects and lines
The experienced Valicare project managers ensure the GMP-compliant realization of your regulatory projects.
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 is your competent consulting partner. Professional and internationally experienced project managers and flexible engineer teams ensure compliance with both regulatory and individual requirements.
Our engineers are very familiar with aseptic filling, isolator systems, inspection technology, as well as huge biotechnological and pharmaceutical production lines. Validation of processes, cleaning procedures, and analytical methods as well as design reviews and regulatory “due diligences” are regularly on their task list.
In cooperation with our mother company Syntegon we have hands-on experience and access to a broad spectrum of pharmaceutical standard technologies. We can draw on the support and assistance of the global Syntegon organization.
Contact us if you have any questions. We will gladly answer and advise you.
