Method development, Validation and Transfer

nuvalore uses Design of Experiments (DoE) in addition to conventional approaches to develop robust analytical methods in agreement with the ICH Q14 guidelines. The results can be integrated into the validation and method transfer if needed.

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Method development, validation and transfer

The application of Analytical Quality by Design (AQbD) leads to a reduction in the number of required laboratory investigations, improves the method transfer and accelerates adjustments within the analytical method life cycle. The focus is on quality control (QC) methods for testing of parenteral and oral medicinal products. Our experienced scientists validate the methods according to predefined test protocols and transfer the robust methods.

Data integrity is a top priority for us, and your raw data and reports are in safe hands with us.

nuvalore GmbH

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+49 (6224) 179 966 0

nuvalore GmbH
Paul-Ehrlich-Str. 1
D – 69181 Leimen

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+49 (6224) 179 966 0

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