Hetal Katrodiya

At mAbxience, I define and execute global CMC regulatory strategies for biosimilars across EMA, US FDA, MHRA, and TGA markets, including MAA/BLA variations, INDs, CTAs, and Health Authority responses.

I've led FDA query-response teams supporting commercial approvals for Releuko and Fylnetra, contributed to EMA approval for Grastutek, and supported an EMA-approved Adalimumab drug-substance manufacturing-site change. My work spans Module 2 and 3 dossiers, analytical similarity, process comparability, and post-approval manufacturing changes.

Across Kashiv BioSciences, USV, Reliance Life Sciences, and Zydus Research Centre, I've built analytical and regulatory development experience for mAbs, fusion proteins, cytokines, Pegfilgrastim, and Exemptia.