The Road That Makes All the Difference

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. At RAAHA, we pride ourselves on our high quality services and the meaningful relationships we build with our clients.

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In 2021 and 2022, our very own Dr. Aloka Srinivasan participates in several conferences and workshops related to controlling nitrosamine impurities in pharmaceuticals and how to successfully work with 505(b)(2) NDAs.

In 2021, 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.

Dr. Srinivasan is also a member of the 505(b)(2) Platform and participated in several workshops related to challenges experienced by industry in developing products which may fit the 505(b)(2) pathway. Interested in having Dr. Srinivasan speak or provide her expertise at a relevant meeting, event, or conference?

Reach out and let her know via LinkedIn or fill out our contact form!

Principal and Managing Partner

Dr. Aloka Srinivasan, Principal and Managing Partner of Raaha LLC

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.

Consulting Services

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.

Regulatory Strategies

Develop regulatory strategies for high barrier, complex generics and improve branded versions of approved molecules

Prepare and Review Documents

Prepare and review NDAs, 505(b)2 NDAs, ANDAs, DMFs, INDs, Controlled Correspondences, and Citizen Petitions

Life Cycle Management

Life cycle management of ANDAs, NDAs, DMFs, and INDs

Provide Early Guidance and Support

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

Integration

Integrate all aspects of the Regulatory Affairs discipline, following mergers and acquisitions

Due Diligence Audits

Regulatory filing due diligence audits.

180‐day Marketing Exclusivity

180‐day marketing exclusivity regulatory challenges by FDA and competitors.

Pharmaceutical Development

Pharmaceutical development of drug substances and drug products.

Training Sessions and Workshops

Conduct training sessions and workshops related to various aspects of drug development.

Advise on CMC 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 Potential Mutagenic and Carcinogenic Impurities

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

Latest
Blog Posts

8 Dec
Nitrosamides – Should They Be Treated the Same as Nitrosamines?

Nitroso compounds are formed by the reaction of secondary and tertiary amines, amides, carbamates, urea, guanidine with nitrite or other […]

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