- Pre Clinical Safety Evaluation of candidate drug substances, biopharmaceuticals and vaccines.
- Regulatory Toxicology.
- OECD Principles of GLP and other regulatory guidelines.
- Safety Pharmacology Studies.
About 13 years experience in Pre Clinical Safety Evaluation-Toxicology. Started career in 2001 as a member of the Toxicology team with Dr Reddy’s Laboratories Limited, Discovery Research, after pursuing Masters Degree in Veterinary Clinical Medicine and Therapeutics. Following this, worked with Dabur Research Foundation with the responsibility of planning, conduct and reporting of Toxicity studies in rodents.
Thereafter worked in the Department of Safety Assessment, Advinus Therapeutics Private Limited as Study Director for several rodent and non rodent Safety Pharmacology studies.
During these periods involved in putting in place GLP systems, SOP preparation and implementation, successfully undergoing several inspections by GLP monitoring authorities. Also involved in the capacity of Study Director / Technical Coordinator in design, conduct and evaluating the preclinical safety of numerous candidate drug substances, biopharmaceuticals and vaccines to international standards – guidelines, fulfilling Good Laboratory Practice (GLP) requirements.