Through IND-enabling studies, our team delivers essential data that helps pharmaceutical companies transition their drug candidates from preclinical research to clinical trials. By integrating sophisticated bioanalytical method development, toxicology studies, and pharmacokinetic analysis, our scientists create robust data for regulatory submissions that align with FDA requirements.

IND-Enabling CMC

From drug characterization and impurities analyses, to complete analytical method development and validation, our state-of-the-art instrumentation allows for robust methods for both API and finished product specifications. With our stability chambers and wide fleet of HPLCs, Mass Specs, and further analytical equipment, our experienced team also provides complete stability studies.

Our comprehensive inclusion of CMC and Bioanalytical testing enables precise quantification of drug levels, impurity profiles, and critical safety indicators – providing the comprehensive evidence needed to demonstrate a compound’s suitability for human studies.

Our expert scientific team execute IND-enabling studies that fulfill regulatory demands while maximizing efficiency and cost-effectiveness. Each program incorporates essential components including analytical method development and validation, comprehensive dose range-finding evaluations, GLP-compliant toxicology studies, and detailed stability assessments. Meticulous documentation practices and stringent quality control protocols ensure all data generated fully complies with regulatory requirements, forming a complete and robust data for IND submission. By fostering close collaboration throughout the development process, we guide clients through intricate regulatory pathways and establish the groundwork needed for successful progression into clinical trials.