How to access analytical development and validation solutions for strategic decision making.
Optimize your chances for approval
Access scientific data for strategic decision making
Whether you are in early development or commercial drug manufacturing, access to your drug product’s high-quality scientific data is critical. When it comes to regulatory submission, this scientific data can help with drug product efficiencies and strategic decisions. It also is valuable with each part of the process and aids in strategic decisions because it helps back up the quality of the product and processes you built. With fully equipped cGMP labs, Thermo Fisher provides comprehensive analytical solutions to help transform your discovery into a drug product with the best chance for approval by leveraging:
- Physical and chemical characterization
- Pre-formulation studies
- Method transfers—both analytical method risk and method validation gap analysis
- Raw material release testing
- Drug product release testing
- Component compatibility testing
- Product contact part compatibility testing
- Container-closure integrity studies
- Method development and validation
- In-process drug product testing
- Clinical trial material stability testing
- Cleaning method development and validation
- Microbiological method development and validation
- ICH stability testing
We have cGMP labs staffed by highly experienced teams within each of our manufacturing and development sites. From a small quantity of your drug substance or drug product, you can gain the scientifically sound data you need for regulatory submissions and to guide your next steps. We provide through analytical data for high-quality products, processes, and business decisions, such as:
- Chromatography: GC, HPLC, and UPLC
- Spectroscopic: UV, FTIR, ICP, and AA
- Moisture analysis
- Rheology
- Particle size analysis
- Thermal analysis
- TOC
- Dissolution analysis
- Thin layer chromatography
