How to access analytical development and validation solutions 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. Scientific data adds further value to each phase as it aids in strategic decision making—it helps back up the quality of the product and processes you built. With fully equipped cGMP labs, Thermo Fisher Scientific provides comprehensive analytical solutions for your OSD drug product.
Early development analytical solutions:
- Physical and chemical definition analysis
- Method development and validation
- Impurity tracking
- In-process production support
- Stability testing for various ICH climatic zones
- Genotox studies
- PAR studies
Commercial manufacturing analytical solutions:
- In-process control production support
- Release testing
- Stability testing for various ICH climatic zones
- Genotox studies
- PAR studies
- IND/IMPD dossier support
