PROFESSIONAL STAFF Please click on a name to send an e-mail.   Thomas Shotwell, Ph.D. - Chairman of the Board (Emeritus) FDA, USDA, & EPA regulatory systems Risk Management Principal function is to assure client awareness of current and impending regulatory requirements and to guide developmental research programs so as to better assure federal approval for marketing of health related products in the United States and Canada. Federal approvals have been obtained for clients to market several hundred drugs and pesticides.   Paul W. Carr, P.E., R.A.C. - President FDA & EPA product approval applications Chemistry, manufacturing & controls Facility audit & design Expertise is provided in the areas of: state and federal regulatory requirements; preparing, editing and submitting product applications; good manufacturing practice audits and preparing standard operating procedures; manufacturing facility design (all dosage forms including sterile facilities, clean rooms, biotechnology); plant audit and training programs and representing clients before federal and state agencies.   Mark L. Shepard, M.S. - Vice President Protocol & report review Submissions preparation Responsible for advising client firms regarding regulatory affairs relating to drug product research and development activities, and for meeting with officials of the FDA on behalf of client firms. Prepare new drug applications (animal and human), abbreviated applications, drug master files and supplements and amendments for same according to FDA (FD&C Act) regulations. Scientific review/editorial function for study protocols, research reports and technical papers related to animal and human drug submissions. Clinical trials monitor.   Barry Pearce, DMS, MIMgt - Vice President European Operations Medical device submissions Quality systems and audits Medical devices and in-vitro diagnostic devices European Authorized Representative to U.S. medical device companies Based in England in order to support both US and European clients in preparation and implementation of quality and manufacturing systems to meet US and European requirements. Preparation of FDA 510(k) submissions, European Technical Files and conducting "friend of the company" compliance audits.   Denice Gallagher - Regulatory Consultant Drug product submissions Medical device submissions Medical device quality systems & audits U.S. Agent for foreign medical device companies Responsible for preparation of FDA 510(k) submissions & "friend of the company" compliance audits.  Preparation of new drug applications, supplements and drug master files, as well as drug experience reports and minor change & stability reports. IN THE U.S.: Phone: 888-326-3311 Fax:     972-446-6622 E-mail: Webmaster IN THE U.K.: Phone: +44 (0) 1243 779550 Fax:     +44 (0) 1243 781563 E-mail: bpearce@shotcarr.com