THE ACG TEAM

The Arkin Consulting Group is led by Ron Arkin, President, and Paul Sumner, VP of Regulatory, Clinical & Quality Systems.  These professionals are experienced industry leaders and are selected to work on a project team according to the specific needs of the client. Other members of the group add their expertise in areas such as: biomedical disposal; chemical engineering in sterile/non-sterile solutions; regulatory compliance with EPA and OSHA; manufacturing processes and procedures; research and development clinical study protocols; adverse event evaluation; budgeting, work scheduling technical trouble-shooting; manufacturing management training; supplier/vendor facility audits; device labeling, marketing literature and more.  Our strong network of contacts also include FDA attorneys.

Ron Arkin is a highly qualified medical products professional with more than 25 years experience in regulatory affairs, quality assurance, sterilization and validation.  His experience includes managing an Ethylene Oxide facility for the world’s largest EtO sterilization company and overseeing the first contract sterilizer in the Southeast US to operate with no FDA citation.  He is also an educator, having taught college level didactic and clinical medical courses, lectured at FDA-GMP workshops and conducted seminars on auditing, process validations, quality system regulations, and other issues related to medical devices and drugs.  He has a BA in Physiology and an MS in Biological Science from Southern Illinois University.   Ron is a member of the American Society for Quality (ASQ) and the Regulatory Affairs Professional Society (RAPS), a Medical Device HACCP Instructor and is a trained ISO-9000 lead assessor.

Paul Sumner, as a senior member of Arkin Consulting Group with over a twenty five year healthcare industry track record, provides advice for medical device and pharmaceutical companies in the areas of regulatory, quality and clinical matters relating to the U.S. Food and Drug Administration (FDA) and the International Standards Organization (ISO). With seasoned industry experience, he provides regulatory consulting, strategic planning, marketing submissions, manufacturing compliance, quality systems design and implementation, auditing, design and process validations, training, and compliance crisis management for clientele. Some of his areas of expertise include FDA regulations, ISO standards, QSIT, QSR, Design Controls, 510(k), IDE, and PMA Submissions, Process and Product V&V, Process Improvement; and 483, Warning Letter, MDR, and Recall Resolution. With an education in Business Administration and Computer Information Systems, Paul has held senior executive management positions in all facets of business, including disciplines of regulatory and quality, for start-up to medium sized multi-national, high technology, and culturally diversified healthcare device companies serving advanced evolving medical therapeutic and diagnostic device technologies ranging from diagnostic imaging to cancer detection and life saving therapies, where he strategized and effectuated worldwide registrations, commercial introductions, distribution and pre- and post-sale compliance for existing and new products and business entities.