Analytical Method Validation

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Analytical Method Validation

Method validation is one of the most crucial component in any regulatory submission.

Our validation protocols and reports are based on globally accepted guidelines such as ICH, FDA &USP requirements and cover various parameters.

We are capable of validating methods to support for various types of formulations.

We perform method validation as per ICH Q2 requirements, meeting 21 CFR Part 11 regulatory requirements for data integrity.