Build My CMO Oversight Program
What You Are Dealing With
You outsource manufacturing and you are responsible for everything that happens at your CMO’s site, even though you are not there every day. When your CMO has a quality problem it becomes your quality problem, and you may not find out about it until it shows up in an audit, an inspection, or a batch failure. The oversight structure most companies have in place is not enough to give them a genuinely accurate picture of how their CMO is actually performing. You need an independent view and a framework that holds up when the FDA asks how you are managing your contract partners.
How We Approach It
We build the oversight structure that gives you real visibility into your CMO relationships. That means quality agreements built to the right standard, audit programs that produce an independent and accurate picture of performance, and monitoring processes you can defend to leadership, a board, or a regulator. We conduct the audits, deliver the findings, and help you manage your CMO to a standard that protects your product and your company.
What We Have Done
A pharmaceutical sponsor that outsourced manufacturing, packaging, and testing engaged MEDVACON to conduct cGMP and quality audits across its CMO and contract quality control laboratory. MEDVACON provided an independent assessment of both partners and delivered findings the client could act on.
A pharmaceutical sponsor that outsourced manufacturing, packaging, and testing engaged MEDVACON to establish a full CMO oversight and quality governance framework across its external partner network. Our team supported the development of quality agreements, defined roles and responsibilities, ongoing monitoring processes, and a structured audit and performance review program.