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Validation Services

Reliance on testing finished products alone is not enough to guarantee safety & quality.  Manufacturing equipment, facilities, product, devices and methods must all be validated through the implementation of quality systems.

Sterility test validation.  The sterility test is not a ‘one size fits all’ test and, development of the right test for the product takes skill and experience. 

From product development to post market support, whatever your validation challenge Helvic are here to help.  Our experienced team can help you with partial validation, re-validation as well as full validation studies.

Development Services

Helvic provides method development and validation for protocol design. We support and interact with our customers at various stages throughout the development of the validation process. This, coupled with our experience, ensures a method that meets your specifications and is validated for its intended use.

All validation works at Helvic are developed and performed in accordance with current Good Manufacturing Practices (cGMP).

We can provide a full development service including protocol development, validation in accordance with ICH guidelines or in-house requirements and Analytical Method Transfer (AMT).

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