Since founding in 2002, the Valicare GmbH has carried out more than 5.000 successful ISO and GMP compliance projects with international (bio) pharmaceutical key accounts and manufacturers of medical products.
Our focus is on consulting, risk and quality management, audits and inspections, as well as the risk-based qualification and validation of pharmaceutical, mainly aseptic filling lines, and processes.
Over the last years, we have developed a special focus on the support of customers in the development and manufacture of novel medicinal products and investigational drugs, so-called ATMPs (advanced therapeutic medical products).
Our teams have gained a great deal of experience in the efficient handling of complex customer-specific projects in the pharmaceutical, biotechnological and medical device industries and established a loyal customer base.
With pleasure we set up a references list, referring to your planned project.
Here you get a first overview about the relevant regulatory requirements, regulations, laws as well as competent authorities and organisations in Germany, Europe and US, that are important for ATMPs.