We recently expanded our service coverage into GLP- and GMP-compliant activities within the CMC and bioanalytical areas of operation, and are in the process of establishing GMP aseptic processing. We are now better positioned to serve client's needs as they progress into IND-enabling pre-clinical work and early clinical development studies.
GLP Services
Analytical method validation and stability testing
Dose confirmation
Bioanalytical method development and validation, and PK analysis
Manufacture and fill finish of test and control article
GMP Services
API and drug product characterization
Reference standard characterization
Stability testing
Analytical method development, qualification, and validation
API and drug product physiochemical comparability studies
Quality assurance and quality control contract services
