Small Molecule Analytical Chemistry
Activities By Development Phase
TEST ACTIVE PHARMACEUTICAL PRODUCTS FASTER AND MORE EFFICIENTLY
Catalent Benefits Catalent Services
Catalent utilizes a step-wise approach for analytical testing. The activities completed are appropriate to the phase of the drug development. Analytical activities will be completed with reference to International Conference on Harmonization (ICH) requirements, or any globally relevant regulatory guidance, whenever appropriate.
CATALENT BENEFITS
To ensure your project’s success, we are committed to providing:
- Single point of contact for all phases
- Assurances that current guidance’s are met
- Effective communication
Catalent Services
Preclinical
- Non-GMP
- GLP
- Preformulation and solid-state characterization services
Early Phase Clinical
- Phase-appropriate validation
- Assessment of prototype formulations
- First-in-man studies
- Clinical trial material
Late Phase Clinical / Pre-Commercial
- Registration
- Design of experiments/Quality by design
- Process validation
- Photostability
- Temperature excursions/Shipping studies
- Shelf-life, expiry dating
- Packaging component assessment/interactions
Commercial
Phase IV / Line Extension
