The Alcami Advantage.
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 (NDAs), Abbreviated New Drug Applications (ANDAs) and New Animal Drug Applications (NADAs). Our fully integrated laboratory services are well established and ready to help our clients get the most out of their portfolios.
The advantage of using Alcami is our consistent, flexible, and reliable on-time delivery. The majority of compendial raw materials are released in ten business days or less with an available option for expedited services as short as one day. We have experience in testing a broad range of compendial monographs and vendor specific needs, tailored to your specific requirement — from partial to full monograph testing. Alcami is also known for its industry leading experience and expertise in formulation development, biologics, and analytical method development.
Alcami holds an exemplary compliance record. When you partner with us, you receive access to our analytical centers of excellence ensuring fast and responsive support, along with the industry's best customer service experience.
Full Array of Pharmaceutical Development and Commercialization Laboratory Services
- Early-phase, clinical, and commercial formulation development
- Analytical method development and validation
- Biopharmaceutical analytical development and validation
- Stability storage and testing
- Abuse-deterrence and food study expertise for opioid and pediatric formulations
- Active pharmaceutical ingredient release and stability testing
- Compendial method verification and validation studies
- Compendial microbiological testing to support drug product development, release, and stability
- Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS for all materials
- Container and closure system integrity testing
- Comprehensive large molecule capabilities
- Disinfectant qualification and disinfectant efficacy
- Drug product release and stability testing
- Drug substance reference standard characterization studies
- Extended Workbench offering
- ICP-MS experience and capabilities including elemental impurities per USP <232>, <233>
- Microbial identification by MicroSEQ® (genetic sequencing)
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