Analytical services

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"