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Chanakya Patel

Head of Quality Assurance

Chanakya is a seasoned professional with a distinguished career in Lifesciences and Pharmacovigilance, complemented by a Master’s degree in Clinical Research and dual qualifications in Pharmacy and Law. His career trajectory features pivotal contributions to the CDSCO MoHFW Government of India, with significant roles spanning the Pharmaceutical, Biotechnology, Clinical Research, and IT sectors. He has authored and meticulously reviewed numerous research papers and holds a design patent, illustrating his deep commitment to advancing medical and pharmaceutical knowledge.

His expertise in Pharmacovigilance is thorough, covering critical areas such as signal detection, the development of risk management plans, the compilation of periodic safety update reports, and the crafting of individual case safety reports (ICSR). This extensive knowledge ensures meticulous monitoring and analysis of drug safety data, essential for maintaining regulatory compliance and ensuring patient safety.

Additionally, his skills extend to ISMS Implementation, Data Governance and Compliance, and comprehensive Auditing practices (internal, external, remote). He is proficient in Regulatory Inspection preparation, Organization Risk Management, and Data Visualization. His substantial involvement in Clinical Trials and Regulatory submissions enhances his capacity to manage safety and efficacy reports effectively and to integrate cutting-edge Artificial Intelligence (AI) and Machine Learning (ML) technologies in Drug Discovery.

He has effectively led the development and implementation of Training and Compliance programs, demonstrating an in-depth understanding of various international regulatory frameworks. His expertise encompasses the latest methodologies in Information Security, Quality Management, and Privacy Management Systems, coupled with advanced technologies in AI and ML. This ensures adherence to global standards and optimizes organizational processes.

Dedicated to enhancing team productivity and fostering innovations in technology, he continues to drive significant advancements in healthcare and life sciences staying aligned with the evolving dynamics of the pharmaceutical and healthcare sectors.

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