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Analytical Strategies from Early Development to Validation: Part One

The Role of Analytical Method Development and Validation Drug development is complex and requires great care to ensure that the products we offer our patients are safe and effective. Consequently, drug development is highly regulated to ensure the appropriate controls are applied for all new chemical entities (NCEs), whether they […]

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Getting Started with Chiral Method Development

At Regis Technologies, we have a wide range of columns featuring different chiral stationary phases (CSPs), and we are often asked to recommend one that will resolve a specific set of stereoisomers.  That’s not always an easy thing to do!  But whether you’re looking to create a robust analytical method […]

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When Should I Hire a CMC Consultant?

Deciding when to hire a Chemistry, Manufacturing, and Controls (CMC) expert can be difficult. On the one hand, a CMC consultant can supervise your project from start to finish and provide valuable knowledge throughout the process. On the other hand, Biotech startups need to work within constraints. One common option […]

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Tour the Regis Facility and Learn About Our Capabilities For Custom Pharmaceutical Development and Manufacturing

The History and Development of Regis Technologies Over the past 65 years, Regis has continuously invested in better serving our life science customers.  Below are key dates in our history that document not only our organization’s evolution, but our ever-growing capabilities: Development, Production, and Finishing at the Regis Facility The […]

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Solid State Chemistry During the Early Stages of Pharmaceutical Development

Phase 1 to Phase 2:  What Should Be Done during the Early Stages of Drug Development? Submitting the appropriate information for an IND application, especially the solid state aspects of the drug substance (DS), can accelerate new drugs into clinical trials.  Having the appropriate information from a physicochemical perspective will […]

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