(571) 447-5500

Radhika Rajagopalan

EAS Independent Consultant

Radhika Rajagopalan, Ph.D. is a former Quality Assessment Lead, Expert Reviewer in ANDA Stability Testing at FDA. She has decades of experience with CMC packages including ANDAs, DMFs (Type 2 and 4), INDs, Bio-INDs, OTCs, supplemental new drug applications, novel technology approval, drugs in devices as well as devices co-packaged with drugs. She works with clients to facilitate complex innovator and generic drug product reviews and approvals for nanotechnology products, gels, suppositories, modified release dosage forms, parenteral, drugs in device, peptides, semi-solids, and liposomal drug products.

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