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Cincinnati, OH 45220

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CRC EXPERIENCE


Barbara S. Fant, Ph.D.
President and CEO

Barbara S. Fant, Pharm.D. has over 18 years experience in pharmaceutical and medical device research and development.  CRC is an independent consulting firm that provides clinical and regulatory support services to medical device and pharmaceutical companies to bring investigational products to market.  CRC’s client base includes U.S. and international companies with a focus on start-up and incubator companies developing novel medical devices.  CRC has successfully filed over 30 IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA in the past four years.  In addition to ophthalmics, therapeutic areas of expertise include imaging technologies and orthopedics.

Dr. Fant is the principle regulatory consultant and owner of CRC.  Prior to founding CRC, Dr. Fant spent several years directing and managing anti-infective clinical trials and pharmacokinetic studies with a major pharmaceutical company; established and directed a highly successful Phase I/Phase II academic-based clinical pharmacology research center at the University of Cincinnati; served as the vice chairperson and associate administrator for an independent institutional review board; and, was an assistant director for clinical research for a large contract research organization. 

Dr. Fant is recognized as an expert in FDA regulations pertaining to medical devices with extensive experience in developing ophthalmic medical devices.  She currently serves as the chairperson for the ANSI Z80.11 subcommittee, which is working in conjunction with FDA to develop an approved ANSI standard for laser systems for refractive surgery and which will also be presented to ISO for consideration.

Located in Cincinnati, Ohio, Dr. Fant is the founding member of the Integrated Center for Device Development, a unique consortium of consultants with the capability to take unique medical devices from the concept stage through regulatory approval, manufacturing, and distribution.  Dr. Fant also serves on the board of directors for Medennium, Inc., Salpingo Medical, and several charitable and philanthropic organizations in the Cincinnati, Ohio community.  She holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati Medical Center.

contact e-mail: bsfant@crc-regulatory.com


Lena Sattler
Associate Regulatory Consultant

Lena Sattler, B.S.M.E.,  has over seven years of experience in providing laser engineering support services in the U.S., Central America, and Europe.  She is widely recognized for her expertise in corneal topography and LASIK treatment algorithms and works extensively with her U.S. and international colleagues in furthering LASIK technology and techniques.  Mrs. Sattler joined CRC’s staff in 2001, bringing with her a core knowledge in custom LASIK algorithms, database design, and clinical investigator and regulatory experience.  Mrs. Sattler holds a B.S. in Mechanical Engineering from SUNY at Stony Brook, New York, and also serves on the ANSI Z80.11 subcommittee for the development of an ANSI standard for laser systems for refractive surgery.      

contact e-mail: lesattler@crc-regulatory.com


 

 A founding partner of the
Integrated Center for Device Development


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