Method development & method validation

Sortis pharma has considerable experience in developing analytical methods throughout the entire drug lifecycle. Initial tests are performed and formally validated following ICH guidelines, including preparation of validation protocols and reports. We adapt validation programs in line with your quality requirements and development stage to provide the most cost-effective solution.

Applications include:

Quality Control of APIs, starting material, intermediates, finished pharmaceutical products
Stability testing
Substance characterization
Formulation development
Cleaning validations
Packaging material testing, especially for extractable and leachable

Methods developed at Sortis pharma can be readily applied to perform routine analyses in house or alternatively can be transferred. If required, we also offer direct method transfer OR training at your facilities.

Services offered

Analytical

Method development & method validation

Applications include:

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