Bringing pharmaceutical, PCPs or
We can help you navigate regulatory & compendial guidelines
medical devices to market?
Through our broad technical expertise, we support all phases of the product life cycle. We have a wealth of experience assessing raw materials, active ingredients, process intermediates, and finished products, from research through commercialization. Our techniques include: assay/potency determination, purity/impurity/degradant assessment, cleaning validation analysis extractable/leachable testing, residual solvents, elemental metals and more.
Our experience with method development and feasibility crosses multiple industries and technologies and encompasses optimization, validation, transfer and verification. We follow compendia methods (USP, EP, JP), client-supported methods and methods we’ve developed and validated for clients. Additionally, our capabilities and expertise support both instrumentation and wet chemistry including:
- In-Process and Product Release Testing and Retain Program Administration
- Stability Testing and Stability Indicating Method Development
- Comparative Product Testing
- Raw Material Testing (USP / NF, EP, JP)
- Quality Control Release Testing
- Impurities Testing