Analytical development is critical in regulatory compliance, (bio)pharmaceutical companies have to provide evidence of the quality of their products. Analytical methods must be fit for their intended purpose and product specifications have to be developed. These analytical methods are used throughout the drug development process, from early-stage development through commercialization for e.g. in-process, release and stability testing, and product comparability studies.
During development methods may have to be transferred to other laboratories with the ultimate goal to demonstrate that methods at the receiving laboratories operate in a qualified or validated state.
We have many years of experience in the development, validation and (global) transfer of analytical methods. We can help you in CMC analytical development activities in early-stage development through commercialization.
These activities may include:
- Designing and evaluation of method qualification, validation and transfer studies
- Support in (statistical) evaluation of qualification, validation, robustness and transfer studies
- Designing and evaluation of comparability studies
- Designing and evaluation of stability studies.
- Writing and reviewing of analytical CMC documentation part of regulatory filings (e.g. IMPD/IND, NDA/BLA/MAA).
- Solutions for continuous method performance verification.
- Support in specification development
- Project management support
If you are interested and would like to discuss opportunities please feel free to contact WPC.
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