Ms. Rao joins DRA as a Senior Regulatory Publisher with over 11 years of industry experience.She has substantial experience in formatting, preparing, and compiling various submissiondossiers (INDs, CTAs, NDAs, BLAs and MAAs). Ms. Rao has an in-depth understanding ofindustry regulations, standards and guidelines of the US FDA and ICH, along with an expertisein 21CFR compliance, GCP, GLP and EU basic laws. She also has experience withsubmissions to GCC, EU, UK, CA, SwissMedic.
Prior to joining DRA, Ms. Rao was a Manager of Regulatory Operations at Premier Consulting where she managed the day-to-day submissions of original and lifecycle applications.