Viren Kothule

Background

About Viren Kothule

Seasoned Toxicologist and Biocompatibility Specialist with 11+ years of experience in non-clinical R&D, drug safety evaluation, and toxicologic pathology. Adept at leading cross-functional projects, managing timelines, strategizing methodologies and coordinating multidisciplinary and multicultural teams to deliver high-quality biocompatibility and toxicological deliverables across pharmaceuticals, medical devices, and consumer goods.Proven track record in designing and interpreting toxicology and biocompatibility studies across pharmaceuticals, medical devices, and consumer goods. Skilled in regulatory toxicology, risk assessment (PDE, ADE, TDI), and biocompatibility evaluations, with hands-on experience in GLP-compliant environments. Strategic Thought Leader for navigating global regulatory frameworks (FDA, EMA, WHO, ISO) and translating complex data into actionable safety insights.Core Competencies- Project & Program Leadership - End-to-end management of toxicology and biocompatibility projects with strategic planning and regulatory alignment- Team & Competency Management - Leading cross-functional teams, fostering collaboration and driving operational excellence- Strategic business development - Service portfolio expansion, client acquisition, and proposal development- Client Handling & Stakeholder Engagement - Strategic handling of global clients, providing expert consultation and regulatory guidance- Global Regulatory & Risk Expertise - Proficient in global standards (FDA, EMA, WHO, ISO) and risk assessments (PDE, ADE, TDI)- Scientific Strategy & Innovation - Standardizing best practices, and advancing biocompatibility and toxicological capabilities.