Mr. Ashutosh Bhatt
Chief Scientific & Quality Officer (CSQO)
Mr. Ashutosh Bhatt is a young, distinguished leader in Kalintis Healthcare; his imposing approach to project management, regulatory affairs, quality assurance, and quality control ensures that the organization meets and exceeds industry standards.
He has established a comprehensive Quality Management System at Kalintis, ensuring consistent, sustainable, and self-efficient compliance and quality at each stage, from receiving materials to the final supply of drug substances.
Under his leadership, the company has strengthened its quality, regulatory, and compliance frameworks for global supply. His ability to foster collaboration across departments and with customers has enhanced operational efficiency, supported timely delivery commitments, and consistent product quality.
Mr. Bhatt's commitment to excellence is evident in his proactive, efficient, and realistic implementation of regulatory guidance into realization, submissions, and Life cycle management of USDMFs, CEP, and Dossiers, timely resolution of CRLs, Deficiencies, and customer needs, management of regulatory and customer audits, and organization's continuous compliance management agendas.
By cultivating a quality and continuous improvement culture, he empowers his teams to achieve high performance. His mentorship and training initiatives have built a knowledgeable, skilled, and dedicated workforce, upholding the highest standards across the company.