In addition to the basic product quality control, the following connected services are offered, which are required throughout the product development or before the market launch of the respective products:
- GMP for excipients, risk assessment and conceptual design of the appropriate scope of the test, and stability studies (EU guideline of 19.03.2015)
- Quality control of raw materials
- Formulation screening and compatibility testing in product development
- Production of small batches for screening and quality-related tests
- Development of analytical methods
- Validation, optimization of analytical methods
- Preparation and conceptual design method transfer
- Cleaning validation
- Transport validation
- Solubility tests (pH profiles, solvents, modifiers, surfactant)
- Biopharmaceutical characterization (profile comparisons of WS release, including method development of dicriminatory methods, method validation)
- SUPAC studies (including method validation)
- lifecycle management "old methods"
In cooperation with our partners innovative methods, eg for particulate systems, nanoformulations, can be implemented in the regulated environment.