Lot Release Testing
Mycenax’ lot release testing program offers an extensive range of high-quality analytical test methods for each stage of product manufacturing and for testing in accordance with GMP and global regulatory requirements.
You can choose between establishing your proprietary analytical methods for your product or adopting Mycenax’ in-house analytical methods to save time and costs.
- Reliable lot release testing in accordance with GMP and global regulatory requirements
- Monitoring and inspection of the production environment in compliance with GMP
- In-depth impurity analysis and monitoring
- Conduct and planning of stability studies in accordance with ICH and global regulatory requirements
- Longstanding in-house experience with established methods
- Establishment of new methods based on scientific principles and systematic experimental design to ensure robust and reliable method performance