Tailored analysis built around your goals and timeline
Developing your new drug product can be time-consuming and costly. You need to work with an analytical development partner that has the experience to keep your project aligned with your development goals.
Our analytical scientists combine phase-appropriate method validation with our drug product characterization services to make sure the correct methodologies are used at every stage.
We structure this process around your specific needs, but an example could include:
- 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
- Pharmaceutical 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
Pharmaceutical method development using industry-leading practices
For optimum responsiveness, we have located state-of-the-art pharmaceutical analytical laboratories at each of our integrated product development sites. As a result, we can provide rapid analytical services to fit your development timelines. Bring your product to market faster, and with reliable results.
As a true end-to-end partner, we provide full analytical method testing from preclinical development through to late-stage clinical and commercial production of API, intermediates and finished drug products. This includes:
- Preclinical prototype evaluations
- Excipient compatibility studies
- Drug product characterization services that analyze purity, dissolution and physical profiling
- Full range of ICH stability studies (storage and testing)
Extensive experience
We have decades of experience in pharmaceutical analytical services. We can bring this expertise to your particular development project, and achieve unparalleled results together.
International presence
With operations across five continents, we have scale that most analytical providers simply cannot equal. This allows us to provide responsiveness at a local level, while utilizing our international network of experts.
Comprehensive solutions
Our approach to pharmaceutical method development is built around your requirements. With state-of-the-art technology and a tailored approach to analysis, we can work with you every step of the way – from preclinical development to commercial production.