Analytical method development and validation Services

Energon Labs can develop and validate methods for raw materials, excipients, drug substance and drug products. With our diverse experience and research background we work with you to develop and validate a method to meet your specific requirements. Method development and validations are done compliance to compendial and regulatory requirements as per ICH Q2 (R2) guideline “Validation of Analytical Procedures: Text and Methodology” and USFDA guidelines.

For compendial products we can support method verification   as per USP , EP and JP.  Energon Labs can draft and execute method transfer protocol/ program as per WHO 961, Annex 7. All incoming methods will be thoroughly checked for performance characteristics through partial validation, lab-to-lab co-validation and comparative testing to generate a comprehensive documentation (plan, protocol and report).