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Genotoxic Impurities in Manufacturing
October 11, 2022
Digital Conference8:30AM EST // 1:30PM BST // 2:30PM CEST

Aloka Srinivasan
Principal and Managing Partner at Raaha LLC, USA


  • Aloka Srinivasan, Ph.D., the Principal and Managing Partner of RAAHA LLC ( brings more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the U.S. FDA in the Office of Generic Drugs, Lupin Pharmaceuticals, Lachman Consultants and PAREXEL International. She provides strategic guidance to the pharmaceutical industry on regulatory and chemistry, manufacturing, and controls (CMC) for drug products and drug substances at all stages of development and for all types of regulatory submissions.
  • Dr. Srinivasan has supported the development of several new drugs and generics during her tenure in PAREXEL and Lachman from the CMC and regulatory perspective. Dr. Srinivasan has worked closely with the industry and FDA related to development and approval of several complex 505(b)(2) applications as well as complex generic applications. Dr. Srinivasan spearheaded the foundation of a division in FDA related review of drug master files (DMF) for drug substances under GDUFA and played a pivotal role in writing of the FDA Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA and a QbR document for drugs substance, which is part of FDA Mapp. 5015.10. Dr. Srinivasan was one of the main authors of the QbR-QOS (Question based Review-Quality Overall Summary) for ANDAs, which is the current basis of review of generis at CDER/FDA.
  • Dr. Srinivasan is one of the world class experts in the area of nitrosamine impurities based on her research background and has been supporting the industry in addressing these carcinogenic impurities in the drugs.
  • Dr. Srinivasan received her Ph.D. from University of Missouri, Columbia under Dr. Richard N. Loeppky of nitrosamine fame. Her thesis was titled “A study of putative intermediates involved in the activation of beta-oxidized nitrosamines and nitrosation of N-substituted aziridines”. Dr. Srinivasan also spent seven years as a scientist in National Cancer Institute, working for Dr. Larry K. Keefer, researching on nitrosamines in potential nitric oxide donor drugs.

Agenda Sessions

  • A Pathway to Nitrosamine Free (?) Pharmaceuticals - Does the Road Wind Uphill all the Way?