Laboratory Services

Alcami’s integrated and comprehensive development and testing services are well established and ready to assist your pharmaceutical product needs.

 

 

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 (NDA), Abbreviated New Drug Applications (ANDA) and New Animal Drug Applications (NADA). 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 10 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, biotechology, 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 industries best customer service experience. 

Alcami offers a full array of pharmaceutical development and commercialization laboratory services including:
  • Early-phase, clinical and commercial formulation development
  • Analytical method development and validation
  • Biopharmaceutical analytical development and validation
  • Stability storage and testing
Principal offerings:
  • Extensive ICP-MS experience and capabilities including elemental impurities per USP <232>, <233>
  • Microbial Indentification by MicroSEQ® (Genetic Sequencing)
  • Comprehensive large molecule capabilities
  • Abuse Deterrence and Food study expertise for opiod and pediatric formulations
  • Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS for all materials
  • Compendial method verification and validation studies
  • Compendial microbiological testing to support drug product development, release and stability
  • Drug substance reference standard characterization studies
  • Active pharmaceutical ingredient release and stability testing
  • Drug product release and stability testing
  • Stability storage and testing
  • Container and closure system integrity testing
  • Disinfectant qualification and disinfectant efficacy

Read More About Our Laboratory Services Offerings