Dr. Asawari Bapat

Director Quality and Regulatory Affairs
DPB (clinical Pathology), MBBS, PGDHHM (Hospital and Healthcare Management)

Dr. Bapat received her training in Adult Stem Cells at Sydney, Australia at Sydney Cord Blood Bank, a TGA, FACT-NETCORD accredited facility. She also received training in Cryo-Cell International, an AABB facility (American Association of Blood Banking), and a US FDA accredited Cord Blood Bank in Oldsmar, Florida, USA.

 

She has firsthand experience in running both small to large adult stem cell banks and cord blood companies of international repute.  Dr. Bapat has developed a proven track record in successful operational start-ups, and management of international companies. These include an Indo-Australian (Cordlife Cord blood bank) bank set-up, an Indo-US (Cryo-Cell International CBB) and a European-GCC venture (Cryo-Save CBB).

 

Dr. Bapat has experience and expertise accreditation and certification processes for  FACT, AABB, US FDA, 21 CFR, ISO 15189:2007 and ISO 9001:2008, DUBIOTECH, MOH India, MOH UAE. She has successfully navigated regulatory inspections and accreditations as a Principal Investigator/Primary Investigator within 6 months in most cases. She held an honorary chair in setting up cord blood bank guidelines in India (2007), and she is an approved and certified AABB assessor (2009) as a specialist for adult stem cells facilities and cord blood banks.


She has also been highly successful in understanding and developing economically reliable, viable and profitable company models according to their requirements in the first year of operations. This is based on her vast internal industry knowledge and good networking with suppliers and vendors. She has a 100% success record in completing applications for all accreditations and certifications sought by client organizations .

EXPERTISE:

  • 14 years of Experience in Quality, Compliance, Accreditation's and Certifications

  • 10 years of Experience in running successful Adult Stem Cell Facilities and Cord Blood Companies

  • 100% Success in all the Operational start-ups

  • Turning Operations into profits in the first year

  • Developing and Managing Budgets

  • Handling all aspects of technology transfer including evaluations, regulatory guidelines and risk analysis

EXPERIENCE:

Complete aspects of Handling Operations and Quality Management System of facilities including:

  • Adult Stem cell and Blood banking in regards to all the aspects of educational information, informed consents, collection, processing, Cryo-processing and the tests performed in the laboratory as per AABB, FACT, US FDA and other international and regulatory guidelines

  • Management of Suppliers and Vendors by appropriate selection, Supplier evaluations, beneficial contracts through effective networking

  • Management of Medical and Clinical services including Marketing, Logistics and on ground support