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Product Development

Unlocking Product Potential Day-After-Day

Alcami specializes in all phases of pharmaceutical development – from critical preformulation studies to commercial product lifecycle management. Over the past 40 years, Alcami has supported more than 500 Investigational New Drug (IND) filings and over 50 New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and New Animal Drug Applications (NADAs). Our fully integrated, comprehensive development services are well established and ready to help our clients get the most out of their portfolios.

Analytical Development

Alcami offers a fully-integrated analytical method development, method validation, and testing solution with a full complement of advanced analytical and information technologies. From Alcami’s electronic laboratory notebook (ELN) data collection system to its integration with our formulation development, project management, and quality systems, Alcami’s cGMP analytical laboratories are arranged to maximize efficiency and deliver results.

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Formulation Development

Alcami’s formulation development team proactively guides your development program every step of the way – from Compound to Clinic.  Our team is adept at solving challenging formulations for new chemical entities (NCEs) and developing high-performance dose forms to meet today’s consumer needs. We offer early-phase accelerated programs for NCEs and generic drug development for human and veterinary applications (ANDAs and ANADAs).

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