For the last few years, our very own Dr. Aloka Srinivasan has been participating in several conferences and workshops related to controlling nitrosamine impurities in pharmaceuticals and successfully working with 505(b)(2) NDAs.
In 2021 and 2022, Dr. Srinivasan participated in a meeting of trade associations and the U.S. FDA to discuss the hardships experienced by innovators, generic drug manufacturers, and over-the-counter drug manufacturers in detection, control, and risk mitigation related to nitrosamine impurities and the use of molecular weight corrections in justifying acceptable intakes of nitrosamine impurities.
Dr. Srinivasan is also a member of the 505(b)(2) Platform and participated in several workshops related to challenges experienced by the industry in developing products that may fit the 505(b)(2) pathway. Interested in having Dr. Srinivasan speak or provide her expertise at a relevant meeting, event, or conference?
Dr. Aloka Srinivasan, Principal and Managing Partner of Raaha LLC, brings more than two decades of experience in the pharmaceutical industry, including 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 has worked on a broad range of dosage forms and 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 to 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 acquired 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.
Are you worried about nitrosamines, including NDSRIs (nitrosamine drug substance-related impurities) in your drugs?
Dr. Srinivasan, a well-known expert in the field, can help you by performing risk evaluation of nitrosamines, including NDSRIs, present in your drug substance and drug product. She can help your team designed a streamlined root cause analysis and, eventually, a mitigation.
Develop regulatory strategies for high barrier, complex generics and improve branded versions of approved molecules
Prepare and review NDAs, 505(b)2 NDAs, ANDAs, DMFs, INDs, Controlled Correspondences, and Citizen Petitions
Life cycle management of ANDAs, NDAs, DMFs, and INDs
Work with R&D teams to provide early guidance and support to ensure the development of drugs, completeness of filing, high quality of submission, and facilitate ease of review at FDA
Integrate all aspects of the Regulatory Affairs discipline, following mergers and acquisitions
Regulatory filing due diligence audits.
180‐day marketing exclusivity regulatory challenges by FDA and competitors.
Pharmaceutical development of drug substances and drug products.
Conduct training sessions and workshops related to various aspects of drug development.
Advise on CMC aspects of development of broad range of dosage forms including solid oral (immediate and modified release), semi-solid, injectables, inhalation, topicals and other complex dosage forms
Evaluate possibilities of mutagenic/carcinogenic impurities in drug substances and drug products, including nitrosamines and support with control strategies for mitigation of risk related to these classes of impurities
Experienced in participating in depositions as SME related to nitrosamines and other scientific issues in pharmaceuticals.
N-nitroso compounds are a family of carcinogens which are formed by the reaction of secondary/tertiary/quaternary amines, alkyl derivatives of amides/ carbamates/urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state.
“I see—but not by sight alone” – a discussion of FDA’s final guidance, Recommended Acceptable Intake Limits for Nitrosamine Drug […]
Summary of the FDA, UMD Meeting on June 15, 2023, regarding “Mitigation Strategies for NDSRIs: Quality and BE Considerations” Aloka […]