Fully integrated, comprehensive development services are well established and ready to help
Alcami specializes in all phases of pharmaceutical development – from critical preformulation studies to commercial product lifecycle management. Over the past 30 years, Alcami has supported more than 500 Investigational New Drug (IND) filings and over 50 New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA) and New Animal Drug Applications (NADA). Our fully integrated, comprehensive development services are well established and ready to help our clients get the most out of their portfolios.
Alcami offers a full array of pharmaceutical development and commercialization services including
- Early-phase clinical trial material formulation development
- Analytical method development and validation
- Biopharmaceutical analytical development and validation
- Stability storage and testing
- Clinical trial material (CTM) manufacturing
- Oral solid dose manufacturing
- Sterile/Aseptic process manufacturing
- Packaging, labeling and distribution
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