Vikas H. Sathe is a highly experienced pharmaceutical professional with over 35 years of specialization in Quality Assurance, GMP compliance, regulatory audits, sterile dosage forms, and technology transfer. He has successfully led inspections by global regulatory agencies including US FDA, EU, MHRA, and WHO, and is known for establishing strong quality management systems and overseeing aseptic operations and media fill validations with a risk-based approach to compliance.

His extensive background includes contributions to greenfield projects, regulatory submissions, technology transfers, and the development of quality governance models aligned with international standards. Proficient in risk assessment, deviation management, CAPA implementation, and audit readiness, he has played a key role in building quality-focused teams and systems. Leveraging his deep knowledge of regulatory frameworks and industry trends, Mr. Sathe provides strategic consultancy to pharmaceutical companies in India and abroad, supporting their continuous improvement and compliance objectives.

He is a strong advocate for building quality-focused organizational culture and has mentored numerous cross-functional teams, empowering them to meet regulatory expectations confidently. His ability to interpret evolving regulatory guidelines and translate them into practical, facility-level actions makes him a highly valued strategic advisor.

Today, Mr. Sathe provides consultancy services to pharmaceutical companies across India and globally, helping them navigate complex compliance challenges, enhance their quality systems, and prepare effectively for regulatory inspections. His strategic insights and practical experience continue to support the growth and regulatory success of many organizations operating in the highly regulated pharmaceutical landscape.