Arjun Patel Email & Phone Number

Results-oriented professional with extensive experience in regulatory affairs, quality control, and research within the pharmaceutical industry. Adept at managing regulatory projects, ensuring timely submission of documents, and implementing CMC regulatory strategies for consumer products. Skilled in reviewing and evaluating quality documentation, preparing dossiers, and responding to deficiency letters from regulatory authorities. Demonstrated expertise in assessing manufacturing and analytical documents, maintaining compliance with regulatory standards, and handling customer complaints. Strong knowledge of GxP, ICH guidelines, cGMPs, and compendial monographs. Experienced in method validation, analytical method development, and method transfer. Proficient in using analytical instrumentation and performing qualitative and quantitative analysis. Excellent track record of maintaining regulatory records, participating in audits and inspections, and managing deviations and investigations. A proactive team player with exceptional communication and problem-solving skills, dedicated to ensuring compliance, quality, and customer satisfaction.