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
Quality control of raw materials
Formulation screening and compatibility testing in product development
Development of analytical methods (chromatography - release - particle analysis - titration - wet chemistry), this includes the transfer to the regulatory environment, validation and transfer of the test methods
Validation and optimisation of analytical methods
Preparation and conceptualisation of method transfer
Cleaning validation (incl. conception of sampling, training of staff)
Solubility tests (pH profiles, solvents, modifiers, surfactants)
Biopharmaceutical characterisation (profile comparisons oft he active ingredient release, incl. method validation. Comparison of orginator vs. generic drug)
SUPAC studies (including method validation)
Lifecycle management "old methods"