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Mr. Ashutosh Bhatt

Manager-Quality, Regulatory & Compliance

Mr. Ashutosh Bhatt is a Postgraduate in Pharmacy, a dynamic professional with over 11 years of experience in quality assurance, regulatory affairs, and project management at Kalintis. His adaptability and expertise have been pivotal in driving the company's success.

He has established a comprehensive Quality Management System at Kalintis, ensuring consistent compliance and product quality at each stage, from receiving materials to the final supply of drug substances. His approach combines precision with a first-time-right methodology, significantly enhancing product reliability.

He has played a critical role in establishing manufacturing and laboratory facilities at Kalintis. His involvement in the qualification of equipment and analytical instruments has ensured compliant and efficient manufacturing and analytical systems.

In regulatory affairs, Mr. Bhatt excels in dossier submissions and navigating complex regulatory challenges, including addressing CRLs and deficiencies. His expertise ensures timely approvals for projects, meticulously managing the life cycle of DMFs and regulatory correspondences.

In his profound commitment to project management at Kalintis, Mr. Bhatt encompasses every phase, from preliminary discussions to developing and delivering end products to customers. Clear and timely information exchanges, a steadfast adherence to quality, regulatory compliance, and a keen focus on operational efficiency mark his approach.

As a young leader at Kalintis, Mr. Bhatt fosters a collaborative approach, conducive to innovation and excellence. He is instrumental in guiding his team through the intricacies of project development, inspiring high performance and dedication.