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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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Analytical Method Development: Best Practices for Successful Filings – and Beyond

Delay Method Development at Your Own Peril! Small and virtual pharma companies mindful of constrained budgets often defer analytical method development until later stages. But delaying analytical process development from pre-clinical to IND or NDA stages bears its own costs…and they can be exorbitant. Need to Develop Analytical Methods? Start […]

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Specification Setting During Chemical API Development

Over the last twenty years or so, the paradigm behind setting specifications has undergone something of a transformation. Much can be attributed to the adoption of risk-based methodologies, such as Quality by Design (QbD), advancements in technology, and harmonization of world regulatory expectations. The Art of Medicinal Science Specification setting […]

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