Offering regulatory experience ensuring full compliance with GMP/ GVP/ GDP standards, risk management, audits, product quality systems, CAPA management, deviation handling, and SOP documentation across clinical and post-marketing phases. Skilled in auditing manufacturing practices, deviation investigations, quality system maintenance, benefit-risk assessments, and audit follow-ups maintaining high standards of product quality and safety, managing regulatory compliance, and ensuring the integrity of the cold chain logistics. Direct oversight of import, distribution, storage, delivery, and post-market surveillance processes. Ensures alignment with GDP standards through quality agreements, site licenses, and product recalls. Oversight of documentation control and licenses for supply chain compliance, including import/export and storage practices. Involved in auditing and inspections and maintaining compliance with various regulatory frameworks.