Method Validation

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Method Development

Global Pharma Analytics combines a full range of cutting-edge instrumentation with a highly skilled, yet innovative, team of scientists to produce reliable methods that deliver accurate, consistent, and precise results. Our team is experienced in quantifying the concentration of active pharmaceutical ingredient (API) as well as excipients, intermediates, antioxidants, impurities, preservatives, and more within your formulation in order to verify that your product retains the proper characteristics, performance, potency and purity. GPA is the industry expert in method validation and development for analytical chemistry techniques.

In line with our team’s highly-effective method development expertise, our skilled method validation chemists can verify existing methods for your regulatory submissions. Because we have assembled a scientific team with significant experience and broad proficiencies, we excel in designing improvements to existing methods by identifying gaps and proposing a comprehensive remediation strategy. Because we understand time and price concerns are important considerations for companies at the pre-submission stage, we start by working to adapt existing analytical test methods to your drug substance or drug product. Because we operate with a sizeable staff within our sizeable facility, we can develop methods for even the most complex formulations within your timeframe.

At GPA, we are more than an outsource lab, we are your partner throughout the entire process. We can help if you have a method development or validation project that is too complex, needs a larger team, or requires a shorter time-frame than your laboratory can handle. As your partner throughout the development process, we can design detailed protocols for method development and validation which not only meet the rigor necessary for regulatory compliance, but also utilize techniques wide-spread enough for easy transition either back into your lab or to a licensee.

Our team will develop custom CDER/ICH and FDA Method Development & Validation protocols for you based on the established regulatory guidelines. All methods are tested under strict internal and external quality metrics and will provide you with peace of mind.

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