Harsh Patel

I’m a Gold Medalist M.Pharm (Regulatory Affairs) professional with hands-on experience in Medical Device Regulatory Compliance and dossier preparation. I focus on creating and reviewing regulatory, audit, and QMS-related documents with strong organization and communication.

In my role as Executive Consultant Regulatory at H L Associates, I prepared and reviewed documents including DMF, SMF, PMF, BMF, eCTD, CAPA, SOPs, QMS documents, annexures, and risk assessment reports. I also supported documentation for Indian MDR 2017 (CDSCO), EU MDR, and USFDA device registration, maintaining training records and regulatory documentation.

I’ve participated in manufacturing plant visits, handled audit activities, and prepared audit compliance reports to support resolution of non-conformities. I enjoy client coordination and fieldwork related to regulatory documentation, and I’m careful about accuracy across multi-jurisdiction submissions.

Beyond my work, I completed a 3-month RA internship at SV Healthcare and industrial training in the ADL department at Emcure Pharmaceuticals. My academic strength (University Topper with 1st Rank and Gold Medal) complements research projects in regulatory-focused dossier preparation and formulation development, while my tools proficiency includes Excel, Word, PowerPoint, and AI-based productivity and research tools.