Optimizing and Validating Analytical Pharmaceutical Methods

DSI can supervise the development of analytical methodologies for use in the control of starting materials, drug substances, and drug products.

This covers the complete lifecycle of methodology involving creation, optimization, transfer, and validation. DSI has an analytical development team with experience in comprehensive methods development and validation.

Services

  • Development of analytical strategy
  • Analytical testing/Validation strategy
  • Development of IPC & PAT method
  • Development support for drug substance and drug product analytical methods
  • Report documentation

Advantages

  • Ability to stage suitable analytical strategies
  • Gain access to a significantly experienced industry team

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: May 8, 2020 at 4:30 AM

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