Method Development & Validation

Method Development & Validation

A lot of facts have to be considered

The development and validation of a new method often seems to be hard and complex. Prior to the start, a lot of facts have to be considered. Beneath the availability of qualified personal the performance of the new method has to meet internal and general quality guidelines and should be suitable for everyday use. Especially with biotherapeutics, you are forced to follow new analytical paths, as new synthetic pathways are explored continuously.

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In the field of human and veterinary drugs, biologic therapies and herbal medicines we offer.

Development and Validation of New Analytical Methods for:

• APIs and Raw Materials used for Pharmaceutics and Biotherapeutics

• Chemically Defined Substances

• Medical Devices

Development and Validation of Impurity Testing

• Degradation Products in Finished Formulations

• By-Products Resulting from Synthesis of Active Substances made for Pharmaceutics and Biotherapeutics

• Trace Components and Detergents (Tween, Pluronic, Triton, etc.)

• Forced degradation studies