Aishwarya Sarma, M.Sc., DABT, Scientific Consultant 1, Toxicology, Pharmaceuticals & Healthcare
Board Certified Toxicologist with 12+ years of R&D focused industry experience and been responsible for the design and interpretation of toxicology studies for active substances and end-use products in support of regulatory submissions across various geographies in the biopharmaceutical, agrochemical, and food industries. Involved in the risk assessment and safety evaluation of excipients, drug impurities, small and large molecule drugs, consumer products, food contact substances, cosmetics and medical devices. Recognized success at developing and maintaining strong relationships with pre-clinical CROs, regulatory agencies.
Serving as a toxicology subject matter expert on project teams to support product registrations including safety assessments and regulatory submissions globally. Liaising with experts across a wide range of disciplines within the company, industry associations and national or international regulatory authorities to collaborate on cross-active ingredient projects, innovative and alternative toxicity testing approaches communicating data to a wide variety of audiences.
- Experienced in the design and oversight of conduct, interpretation, and reporting of regulatory toxicity studies including, managing and directing CROs.
- Expertise in in silico modeling to address toxicity predictions (Derek Nexus, QSAR
toolbox, OASIS times and Leadscope) - Proficient with design, implementation, and analysis of experiments including:
- All types of in vitro work, flow cytometry, western blotting, microbiology work,
microscopy.
- Assay development.
- Analytical concepts such as descriptive and inferential statistics and tools
necessary for analysis and implementation including Graph Pad Prism and
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