RAAHA LLC

RAAHA walks hand in hand with clients through the drug development process, helping with the approval and life cycle management of generics and new drugs. Dr. Aloka Srinivasan, 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, Parexel International, Lupin Pharmaceuticals, and Lachman Consultants. 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, including NDAs, INDs, ANDAs, DMFs, and products. Dr. Srinivasan worked on a broad range of dosage forms and drug products, including anti‐diabetics, anti‐epileptics, anti‐Alzheimer’s, oncologic, topical antibiotics, NSAIDs, cardiovascular drugs, PDE‐5 Inhibitors, narcotic analgesics, iron‐ carbohydrate products, inhalation and more. Dr. Srinivasan spearheaded the foundation of a division in FDA related review of drug master files (DMF) under GDUFA and has been a representative of the International Generics and Biosimilar Medicines Association (IGBA) in the ICH Q11 Q&A Implementation Working Group (IWGI). Dr. Srinivasan did her Ph.D. on carcinogenic activation of nitrosamines, including NDMA, NDEA, NDELA in cosmetics, drugs, and tobacco. She also spent seven years as a scientist at the National Cancer Institute researching nitrosamines in potential drug candidates. Dr. Srinivasan champions the regulatory efforts of RAAHA’s clients based on her extensive experience and in‐depth knowledge of the U.S. FDA’s regulatory requirements.