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Our Team

MANAGEMENT

Anand Akerkar, Ph.D.
President and Chief Executive Officer

Dr. Akerkar has 40 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 and is currently on the scientific committee to House Majority Leader – Congressman Tom Delay. 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 75 quality systems and led over 100 companies successfully through FDA audits and ISO certification. Alan has trained over 12,000 individuals in cGMP. Mr. Schwartz has over 50 articles published on Quality Assurance and Regulatory Affairs and is a member of the industry group that defined HACCP regulations. He is a Certified Lead Assessor and has been Executive Vice President of mdi since 1994.

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 10 experts that have worked on hundreds of 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 12 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 11 experts that have both developed numerous validation protocols and executed those validations.
    
• Our Clinical Trial team is made up of 8 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 9 professionals who are RAB certified as lead assessors.
    
• Our CE Mark team has 3 individuals who have helped many companies successfully achieve CE Marking under MDD and IVDD.
    

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