Overview
Aligned with the thinking in ICH Q8, Q9 and Q10, there is an increased importance on credible product development and product transfer. All process validation should start with a through understanding of the tolerances of critical control points to quality parameters, i.e. how the process works BEFORE starting validation.
Our Services helps you adhere to FDA guidelines and expectations on Process Validation
- Process Design
- Process Qualification
- Continued Process Verification
Other Services
Technology Transfer
Supporting full technology transfer activities, including: • Transfer of products, processes, and knowledge between sites • Digital transformation of
cGMP Representative Consultant
Our extensive experience in pharmaceutical and medical device industries will ensure that critical compliance issues are on the project plan.