Of greater value than the expertise of a single individual, Pharmatech Associates offers the advantage of validation services that are methodology driven, based on a documented, structured and analytical procedural map that evolves over time in response to changes in regulatory, scientific and business conditions. Constantly tested and upgraded, our methodology ensures a common defined practice, specific vocabulary and consistent results. Pharmatech’s approach is based on real-world industry experience and is tailored to your needs.
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This paper is a comparative analysis between the application of the FDA Process Validation Guidance (2011) to new products and legacy products.