Chief Consultant – Diagnostics & IVD Business
Concept-to-Commissioning Expert | Strategy & Operations Leader | ISO 15189 / ISO 13485 (CDSCO) Compliance Advisor
With over three decades of leadership across Diagnostics-Pathology, Genomics, and In-Vitro Diagnostics (IVD), Sudhanshu Srivastava specializes in building and scaling diagnostic enterprises from concept to commissioning. He has led multiple Greenfield and Brownfield projects, established ISO 15189/13485–compliant laboratories and IVD manufacturing facilities, and advised organizations on CDSCO, NABL, CAP, and MDR 2017 compliance.
His expertise spans Diagnostics and Genomics platforms, IVD product commercialization, business transformation, financial modeling, and strategic growth through M&A and alliances—integrating strategy, structure, and sustainability to deliver measurable business impact. An MSc in Botany from the University of Kanpur and an MBA from IIPM, Sudhanshu combines scientific insight with strategic acumen to drive excellence across the diagnostics and IVD value chain.
Sanjay has been one of the pioneers of improving access to medicines in rural India through the Reachout initiative. He created a new business
model that incorporates a focus on fundamental unmet needs of patients and the creation of a for-profit rural sales force. While focusing on the upper rural tiers 2 and 3, he has
built on the fundamentals of scalability and sustainability to expand these sales operations.