mdi ConsultantsAnand Akerkar, Ph.D.
President and Chief Executive Officer
Dr. Akerkar has over 50 years of experience in the healthcare industry. Anand held several senior management positions at Ciba Giegy, Becton Dickinson, and Technicon Corporation. Dr. Akerkar has successfully managed the development, launch and management of in-vitro diagonostic products. While at Becton Dickinson, he was a member of the industry review board for the FDA that helped to define the 510(K) submission requirements and other clinical chemistry standards. Dr. Akerkar holds 11 patents and has been published over 150 times in recognized scientific journals. Dr. Akerkar has been a consultant to the healthcare industry since 1986. Dr. Akerkar was the Scientific Advisor to ex-U.S. Congressman Benjamin Gilman. He has been President and CEO of mdi since 1994.
Alan Schwartz
Executive Vice President
Alan Schwartz began his career as an FDA investigator in 1972. He rose to the position of supervisor of field operation prior to leaving the FDA in 1978 to start his consulting career. Alan has implemented over 100s of quality systems and led numerous companies worldwide successfully through FDA audits and ISO certification. Alan has trained over 15,000 individuals in the FDA regulations and the QSR/cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and was a member of the industry group that defined HACCP regulations. He has been Executive Vice President of mdi since 1994.
mdi Staff
We have staff around the world that have the qualifications and experience to work on the following topics.
-
- Our FDA submission team is made up of experts, professionals who have done over 2000 510(k)s, PMAs, ANDAs and PMAs. Our experts are former FDA officials and industry executives who have been on both sides of the submission process.
- Our Quality System Implementation team is composed of experts that are FDA cGMP trained and recognized and have many years of industry experience in implementing and running quality systems.
- Our Validation team is made up of experts that have both developed numerous validation protocols and executed those validations.
- Our Clinical Trial team is made up of individuals who have significant experience in writing clinical trial protocols and managing clinical trials. We also have relationships with investigators, statisticians and data managers to fully execute a clinical trial.
- Our ISO team is made of up of professionals who are RAB certified as lead assessors.
- Our CE Mark team has individuals who have helped many companies successfully achieve CE Marking under MDD and IVDD and Health Canada..