A CDMO has to meet its own GMP obligations and each client's expectations, often on the same equipment and systems. We help keep all of that compliant.
Quality and compliance work across programs for many different pharma and biotech clients.
A change to a shared system can affect every client that uses it. Validation has to account for all of them.
Each client's quality agreement says something a little different. Your operations have to satisfy all of them.
Validation work when a product or process moves in from a client or between sites.
A CDMO is adding clients faster than its quality system can absorb them. It needs a contract Quality Systems Manager who has run a multi-client GMP operation.
A biotech is facing its first pre-approval inspection. It needs a mock inspection, a review of its documentation, and confidence that its electronic records will hold up under Part 11 and Annex 11.
A company's supplier audit schedule has fallen behind. An audit specialist plans and conducts the audits and follows each finding until it is closed.
What do you make, what systems are involved, and what is the problem? We will tell you how we would approach it.