PROFESSIONAL STAFF Please click on a name to send an e-mail.   Paul W. Carr, P.E., R.A.C. - President & CEO FDA & EPA product approval applications Chemistry, manufacturing & controls Facility audit & design US Agent for foreign pharmaceutical firms 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 (FDA, QSR) and European (ISO 13485) 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 - Senior Regulatory Consultant Drug product submissions Medical device submissions Medical device quality systems & audits U.S. Agent for foreign medical device companies Quality Systems for pharmaceutical 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.   Denise Rexhaus - Senior Regulatory Consultant Medical Device EU and Canadian Technical Files and Approval Applications Internal and Supplier Quality Audits Worldwide Medical Device Registrations Denise is a UK based regulatory consultant responsible for compiling medical device Technical Files to satisfy EU and Canadian regulatory requirements. She also conducts compliance audits for clients and their suppliers, and assists clients with worldwide device registrations.   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