Research officer
Rallis Research Center
01.1994
- Started carrier in 1994 with Rallis Research Center as Research officer and in the same facility worked under Advinus Therapeutics Ltd. And Eurofins Advinus Ltd until June 2025 as Assistant Director at Adgyl Lifesciences Pvt.Ltd. Bengaluru, India.
- Conducted more than 475 studies as Study Director for Single dose, MTD, Repeated dose 14- Day, 28- Day, 90- Day, 6 months carcinogenicity studies to evaluate safety and toxicity of Agro chemical Pharmaceuticals, Biopharmaceuticals, Industrial chemicals, Vaccines, and Nutraceuticals in rodents and Non rodents following various regulatory guidelines under Good Laboratory practices (GLP) compliance.
- Extensive submission experience with leading regulatory authorities, including the FDA, EMA, and DCGI.
- Spearheaded IND and NDA projects for small and large molecule pharmaceuticals for both FDA and EMA submission.
- Handled toxicology projects for Indian regulatory submissions under Schedule Y guidelines, particularly for pharmaceuticals, ensuring full compliance and robust study design.
- Proficient in Regulatory guidelines: US FDA, OECD & ICH, OPPTS (USEPA), EMA (EMEA) Guidelines.
- Expertise in treating animals in almost all routes by Oral/Dietary/Capsule administration/ Parental route IV/IP/IM/SC, Dermal/Intranasal/Intravesical/Intraarticular.
- Excellent knowledge and experience in assessing Impurity toxicity of pharmaceuticals as per the ICH guidelines.
- Conducted more than 20 impurity qualification studies to test API with 1 up to 10 impurities.
- Conducted intravenous infusion studies through tail vein in rats up to 2 hours
- Involved in successful completion of more than 20 IND studies submitted to Sponsor for FIH approval from regulatory agencies.
- Involved in many Vaccine/ Food additive and Nutrient/ Biologis studies.
- Business generation knowledge from initial 6 cr to 250 cr wide experience in the CRO.
- Improve the turn around time with quality maintaining as per GLP norms.
- Authors for SOPs.
- As study Toxicologist
