Quality Agreements: The REAL Challenges of Third Party Management and thoughts on HOW to ENABLE Robust Execution of the Quality Agreement
I worked for a Chief Quality Officer several years ago who always had this response when our company was contemplating the movement of a large volume of internal production to third parties: “You can delegate your responsibilities but never delegate your accountabilities.” He was a wise man. The Growing Complexity of Third-Party Management I have […]
The Importance of Quality Agreements in CDMO Partnerships
Partnerships with Contract Development and Manufacturing Organizations (CDMOs) have become increasingly essential in the complex and highly regulated manufacturing world. These collaborations allow companies to efficiently bring products to market by leveraging CDMOs’ specialized expertise, capacity, and technology. However, the success of such partnerships hinges on a clear and robust quality agreement, especially in the […]
How To Operationalize a Quality Agreement for FDA Success
The business term “Operationalize a Quality Agreement” stems from my dual background as an attorney and an engineer, with extensive experience in contract work. Contracts are complex because they involve individual and mutual obligations, all in a contextual environment. You need to consider many elements—actions you can take, restrictions, expectations, responsibilities, etc. However, the challenge […]
Companies Partnering with CMOs and CDMOs: Tips on Success
The CDMO and CMO relationships and the whole kind of business dynamic is critically important to the life sciences space. And particularly now with what I what I see, and I think we’ve discussed, an explosion in the biopharmaceutical space. So, there’s a lot of amazing science that’s going on in the bio, the biologic […]
