Analytical Services

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.