I am Dr. Balamurugan Krishnamoorthy, Assistant Vice President – Analytical Services at Malladi Drugs & Pharmaceuticals Ltd., with over 30 years of experience in analytical sciences and pharmaceutical quality systems. My expertise spans analytical method development, validation, nitrosamine and genotoxic impurity risk assessment, and lifecycle-based regulatory compliance.

I have actively contributed to pharmacopeial harmonization and regulatory dossiers (DMFs, ANDAs), and currently serve as an Observer for the USP General Chapters – Chemical Analysis Expert Committee, where I provide feedback on emerging guidance such as USP <1037>, <643>, <645>, <921>, and <1231>.

My scientific mission is to advance evidence-based approaches to nitrosamine risk evaluation and control strategies, integrating Process Analytical Technology (PAT), chemometrics, and multi-compendial testing frameworks. I look forward to engaging with colleagues in the Exchange Group to share insights, discuss evolving regulatory expectations, and collectively enhance patient safety through robust analytical science.