Working with you to ensure appropriate methodologies for all stages
We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages:
- Early handling protocols for your compound
- Analytical methods to support your early drug substance manufacturing process development and formulation prototype characterization including assay, purity and dissolution
- Phase-appropriate methods to support batch release and stability testing of early phase compound, intermediate or drug product manufacturing
- Method optimization to ensure robustness
- Finalization of analytical methods to support your Phase III, registration and commercial drug substance or drug product manufacturing to cGMP guidelines
- Further analytical method optimization to support cGMP process intensification
We provide full analytical method testing from preclinical development through to late stage clinical and commercial production of API, intermediates and finished drug products, for example:
- Preclinical prototype evaluations
- Excipient compatibility studies
- Finished product testing including purity, dissolution and physical characterization
- Full range of ICH stability studies (storage and testing)
For optimum responsiveness, we have located state-of-the-art analytical method-development laboratories at each of our integrated product-development sites, providing rapid analytical services to fit your development timelines.
Our locations
Global, high-quality facilities that bring your molecule to life
Related Offerings
Small Molecules
Related Insights
Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.