Analytical Development & Validation Services
Repeatable, High Quality and Robust Process Design; We offer an in-depth understanding of reaction profiles and the quality and physical form of starting materials, intermediates and the final product are critical components of API (active pharmaceutical ingredient) development. To support route scouting and process development activities and accelerate your clinical programs, we provide a comprehensive range of analytical services.
Our analytical development and Quality Control teams have in-house access to a comprehensive range of state-of-the-art analytical techniques and extensive experience in:
- Development and validation of analytical methods
- Analytical method transfers
- ICH stability studies
- Impurity tracking, isolation and identification
- Reference standard characterization
We have analytical development and Quality Control laboratories staffed by highly experienced teams within each of our manufacturing and development sites. They can provide the scientifically sound data you need for regulatory submissions and to guide your next steps. When those next steps include us, we can use the results of your API analytical activities in the development of your drug product, gaining you significant time and cost efficiency. You can be confident of high-quality analytical data for high-quality products, processes and business decisions.
Obtaining the optimal physical form for your API is important as this impacts downstream product performance. Optimizing characteristics such as size/shape, particle size distribution, flow, density, bioavailability and melting point enables more efficient formulation and manufacturing process development at the drug product stage.