Cerbios provides a full range of analytical services, including methods development and validation, analytical testing and release, stability studies and regulatory CMC documentation services.
In Cerbios, highly skilled analytical chemists, talented in developing and validating phase- appropriate methods, provide method development experimental design, interim progress reports for method development, method validation protocol development and preparation, gap analyses, and remedial method validation as well as customized method validation reports.
Analytical Laboratory Services offered include:
- Method optimization, qualification, validation and transfer
- Release and in-process testing, including expedited services
- Stability protocol development and program management
- Stability storage and testing
- Stability data trending
- Physical chemistry testing
- Compendial testing (USP, EP, BP, JP and FCC)
- Microbiological testing
- Analytical support for cleaning and process validation
- Preformulation testing
- Reference standard characterization
Quality Control also participates in the validation process in order to minimize potential future method transfer hurdles and ensures that a reliable method is in place for customer products.
The service is offered only in connection with the Technology Transfer and production of clinical or commercial batches.