Need assistance with strategic and expert implementation of Manufacturing programs, CDMO management, Compliance issues?
For companies that heavily rely on outsourced services, we can help coordinate third parties and provide strategic guidance on the key components of a program at each stage.
We are here to help with highly experienced and expert advice you can trust!
Multiple manufacturing sites, technology transfers, CDMO organizations?
We have a proven track record of succesfully working with third party technology transfers (including CDMOs), PPQ campaigns and manufacturing campaign management using a risk based approach facilitated by tools such as gap assessments, risk assessments and FMEAs at appropriate stages throughout the life cycle of a program.
Difficulties deploying your internal staff to cover multiple projects at key strategic phases?
We have the expertise and we have been there. We provide support you can rely on. Whether it is for process validation programs or CMC write-up or development of continued process monitoring/verification programs, we get things done in a collaborative and effective manner.