State-of-the-art Analytical Instruments and Software:
Ensuring compliance with regulatory standards
Expert Impurity Characterization and Particle Identification:
Establishing product purity and consistency
Lifecycle Management of QC Methods:
Adhering to ICH, USP, and ChP guidelines for method development and validation
Comprehensive Analytical Support:
Providing expertise throughout formulation development and testing during the drug product filling process
Specification Setting for Release and Stability:
Establishing robust product specifications for release and long-term stability
Through our analytical development services, we ensure that your drug products meet the highest quality and regulatory standards throughout their lifecycle.