|
Where precision meets accuracy
Our Analytical Sciences group apply their deep oligo experience to analytical method development, qualification, verification and validation. We have extensive experience in the technology transfer of analytical methods and the support of CMC/DMF submissions. In addition, we are also able to offer Proof of Structure and Characterization studies and the analysis of Physicochemical properties. Our group of PhD level scientists are focused solely in the area of analytical sciences.
Key services we offer:
Qualification
- published (e.g. USP) or 3rd party method
Verification
- scientifically sound and appropriate for use
- Phase I & II appropriate
Validation
- performance characteristics meet requirements for specification and use
- validation protocols and reports
- QA Review /Approval
- Phase III appropriate
|
