Alcami specializes in all phases of pharmaceutical development and testing — from preformulation studies to commercial product lifecycle management. The advantage of using Alcami is our consistent, flexible, and reliable on-time delivery. We have experience in testing a broad range of compendial monographs and vendor specific needs, tailored to your specific requirements — from partial to full monograph testing.
Alcami holds an exemplary compliance record. 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).
Analytical & Development Principal Offerings:
- 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
- Elemental impurities testing with ICP-MS experience and capabilities per USP <232>, <233>
- Extended Workbench (FTE) offering
- Extractables and leachables testing
- Microbial identification by MicroSEQ® (genetic sequencing)
- Rapid sterility
Watch this video to learn about our newest lab in Research Triangle Park, NC!