Prashant Shevale

Prashant Shevale currently serves as a Regulatory Affairs Executive at Astute Healthcare Limited, where he plays a pivotal role in ensuring the company's compliance with global regulatory standards and facilitating the successful registration and approval of pharmaceutical products. His responsibilities encompass managing complex applications for new drug registrations, including submissions to esteemed agencies such as the European Medicines Agency (EMA), BfArM, PEI, and the European Commission (EC). Prashant's expertise in preparing electronic Product Lifecycle Management (PL) submissions, creating detailed manufacturing instructions aligned with EU legislation, and developing comprehensive packaging materials—such as outer packaging, labels, and package inserts—are critical to maintaining the company's regulatory compliance and market authorization.

In addition to his core duties, Prashant actively collaborates with regulatory authorities to streamline approval processes, ensuring timely receipt of licenses and maintaining existing product approvals through diligent tracking and documentation. His background in pharmaceutical medicine, ocular disease, and medical writing enhances his ability to interpret complex regulatory guidelines and communicate effectively with cross-functional teams. Prashant’s proficiency with tracking systems, high-performance liquid chromatography (HPLC), and data science tools further supports his meticulous approach to regulatory submissions and compliance management.

Driven by a strong desire to expand his knowledge in regulatory affairs, Prashant continuously seeks opportunities to deepen his understanding of international regulatory frameworks, EHS standards, and innovative pharmaceutical technologies. His dedication, combined with his interpersonal skills and critical thinking abilities, positions him as a valuable asset to Astute Healthcare Limited, where he aims to contribute meaningfully to the organization’s growth and success in the highly regulated pharmaceutical industry.