(571) 447-5500

Radhika Rajagopalan works in the pharmaceutical industry and has over 23 years of experience with dosage forms’ CMC sections for both 505(j) and 505 (b2) applications. She is an expert in CMC packages including ADNAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTC ANDAs, supplemental new drug applications, novel technology approval, drugs in device as well as devices co-packaged with drugs and works with clients to facilitate complex innovator and generic drug product reviews and approvals under User Fee Programs for nanotechnology products, gels, suppositories, modified release dosage forms, parenteral, drugs in device, peptides, semi-solids, and liposomal drug products.

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