Our Management Team have over 70 years of experience working on a daily basis with FDA. We have expertise in medical devices, biologicals and pharmaceuticals in the preclinical, regulatory, clinical and reimbursement areas. Our practice is to evaluate your company's existing information, procedures and goals and then proceed to craft a strategy for successfully taking your product through the FDA Approval process, as we have done numerous times before.

In addition, our Scientific Advisory Committee is available for consult on issues ranging from clinical procedures to surgical techniques. The SAC is available for advice and service on the commercial viability of all products.

• Mario J. Reres - Director of Worldwide Regulatory Affairs

  Mario Reres has over 30 years industry experience working with FDA, most recently working as the Sr. Regulatory Adviser at Musculoskeletal Clinical and Regulatory Advisers, LLC. Mr. Reres has a wide-ranging level of experience with pharmaceutical and medical device submission and has established many long-term associations with colleagues, both within and outside of FDA.

  Prior to this, Mr. Reres was Vice President, Regulatory Affairs for Biomatrix, Inc. and was instrumental in crafting the successful approval of Synvisc® as a novel platform technology. He maintained that position until the acquisition of Biomatrix by Genzyme Biosurgery. Mr. Reres has held positions of increasing responsibility within the Regulatory Departments of several major medical device and pharmaceutical firms, including Ayerst Laboratories, Union Carbide Medical Products, Anaquest, and Warner-Lambert.

  Mr. Reres completed his undergraduate degree in Biology at Sr. Francis College, New York and his Master of Science at New York University Graduate School of Arts and Science.