Our Team

Radhika is a consultant for pharmaceutical drug substances, and products, and assists in preparation of dossiers for regulatory submissions to the FDA- CDER during various stages of application process.

Radhika has retired from the FDA, Center for Drug Evaluation and Research after almost 24 years of service in various capacities. She had served as an Expert Reviewer, held both Team Leader position and interdisciplinary position within Office of Pharmaceutical Quality (OPQ) - policy office from Life Cycle Products, during the development and implementation of ANDA stability Guidance. She has delivered 5 FDA guidances during her tenure; hired and mentored scores of reviewers with in CDER OPQ. During her FDA tenure, she also served as a Special Assistant to the Chemistry Director. Prior to FDA, she spent 7 years with the Pharma R & D having worked for both Warner Lambert - Parke Davis division, as well as Bristol Myers Squibb. She has contributed to writing portions of IND, Supplements, and NDAs and worked under GMP. Her experience over the years covers Rx, and Rx to OTC switches.

Radhika has a Ph.D. in Organic Chemistry from Oklahoma State University and has completed postdoctoral research from the University of Kansas, Lawrence in Bioanalytical Chemistry.

She has about 6 yrs. experience with 505 (b, b2) and 505 i) applications for new and generic drug development strategies with companies; assists in FDA deficiencies response preparation, and review device related packages and labeling; trained to conduct mock inspections for drug manufacturing/testing sites on QMS, Laboratory Controls, Reference standard and Equipment Qualification. Experienced in small molecules formulation development and Pre-submission meeting package preparations. Assisted in filing several supplemental applications for NDAs, & ANDAs. She has served as an expert witness in Court cases involving few drugs and product related issues.