Free Guide to Assessment, Qualification & Validation: Managing Risk and Ensuring Success With a Contract Manufacturing Partner


Any long-term commercial relationship, especially between a drug innovator and its CMO, requires a number of things to remain sound: ongoing dialogue, common expectations, milestones and metrics, responsiveness, secure data access and more.  With time, these relational and transactional exchanges build a collaborative bridge that pushes risk out and business success into these highly technical and complex relationships.

The question remains, though, how do you get there from here? How does a prospective drug innovator successfully and strategically assess prospective partners to ensure a long-term and successful relationship? If you are reading this, chances are good you are pondering the same thing.

In this complimentary eBook, we’ve gathered together a sampling of collective industry knowledge that will help you explore:

  • What makes a successful due diligence when in-licensing a pharmaceutical product?
  • What are feasibility studies and how are they used in the pharmaceutical industry?
  • What considerations should be made when planning A feasibility study?
  • Tech transfer’s new framework
  • Validation = Process Design
  • What are IQ, OQ, and PQ, and why are they required?

If you want a resource that helps you think through the fundamental elements and issues that define the technology transfer process and frame what makes this exchange achieve all its intended goals and objectives, this may be the resource for you.

Ultimately, it’s simple; the better the Technology Transfer process is managed, the better its outcomes will be.