Ashutosh has been a key member of Kalintis since its inception, playing a pivotal role in developing the company quality and regulatory infrastructure. He has been deeply involved in every aspect of building the facility from the ground up, assisting in the design and implementation of the GMP framework.
He has established a robust Quality Management System at Kalintis, ensuring consistent, sustainable, and self-sufficient compliance at every stage from raw material receipt to the final supply of drug substances.
Mr. Bhatt's commitment to excellence is evident in his proactive and pragmatic approach to regulatory implementation. He has successfully translated regulatory guidance into actionable processes, overseeing submissions and lifecycle management of USDMFs, CEPs, and dossiers. His expertise extends to the timely resolution of CRLs and deficiencies, addressing customer needs, managing regulatory and client audits, and driving the company's ongoing compliance initiatives.
With a passion for maintaining the highest industry standards, Ashutosh continues to lead Kalintis's compliance and quality vision into the future.