Profesional Services

What We Offer

Arkin Consulting Group offers comprehensive FDA and ISO regulatory, quality and clinical consulting services including:

The ACG Team

All ACG consultants come from the biotech industry and understand the inter-related dynamics of cost, risk and efficiency and work to find the optimum balance for clients. The convergence of expertise and a commitment to relationships with clients, agencies and industry sets ACG apart from other firms.

ACG Consultants:

Ron A.

Ron leads ACG with more than 25 years’ experience in regulatory affairs, quality assurance, sterilization and validation. He succeeds at managing ACG’s engagements by assessing client needs and assembling the appropriate expertise and resources to meet and exceed client expectations. Ron has based his consulting practice on the decades he spent in industry managing regulatory activities and GMPs, and developing validation protocols, process controls, testing and inspection methods for device manufacturers. He managed a 45,000 sq. ft. facility providing technical GMP and sterilization processes to medical device, pharmaceutical, food, cosmetic and packaging industries, and led 30 successful 510(k) and international submissions. He had RA/QA/QC, operations and customer service responsibilities in addition to sales and operating and capital budgets. He managed 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, advising and teaching graduate-level regulatory affairs, college-level didactic and clinical medical courses. Ron has lectured at FDA-GMP workshops and conducts seminars on auditing, process validations, quality system regulations, and other issues related to medical devices and drugs. He earned 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 S.

Paul S., ACG’s Vice President of Regulatory, Quality and Clinical Systems, has more than 25 years’ healthcare industry experience with medical device and pharmaceutical companies in the areas of regulatory, quality and clinical management. 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 clients. Areas of expertise include FDA regulations, ISO standards, QSIT, QSR, design controls, 510(k), IDE, and PMA submissions, process and product validation; and 483, warning letter, MDR, and recall resolution. With an education in Business Administration and Computer Information Systems, Paul has held senior management positions including disciplines of regulatory and quality, for start-up to medium sized multi-national, high technology, and culturally diversified healthcare device companies. His background includes evolving medical therapeutic and diagnostic device technologies ranging from diagnostic imaging to cancer detection and life-saving therapies.

Cathy C.

Through extensive experience and continued contact with different divisions of FDA, Cathy has successfully completed new and supplemental filings often with shortened approval times. She works with clients to establish compliance systems, such as device master records, registration and listing, master labeling and promotional material files and complaints systems. Her lead auditor training is applied to client projects preparing them for and conducting facility, external supplier/vendor and internal audits. She has worked with many clients to establish, qualify and complete process validations for manufacturing and testing. She provides corporate training in quality systems, design control, validation and GLPs. Her broad experience includes preparation and review of Class I, II and III medical device labeling, marketing and sales literature as well as training of sales and marketing staff for verbal claims. Cathy holds an MS in Management from Polytechnic University and a BA in Biology/Chemistry from Mercy College.

Ron H.

Ron’s more than 30-year background in manufacturing operations spans start-up firms as well as acquisition and mergers. His management experience spans C-level manufacturing, engineering, quality, regulatory, technical and clinical groups. His extensive experience developing, implementing and managing quality, regulatory, engineering and clinical systems directly benefits ACG clients. Ron has developed, submitted and obtained approval for IDEs, INDs, 510(k)s, PMAs and C E Marks. He has reviewed and presented technical commentaries and summaries for litigation discovery on medical device manufacturing operations and records, medical device testing, regulatory documentation, medical records, x-rays, and medical device complaint files.

Harvey K.

Harvey’s expertise providing medical device regulatory, engineering services and compliance programs is based on years spent in regulatory affairs and quality assurance. He knows the responsibilities for regulatory, quality control functions and product service functions, having worked in industry as the director of regulatory affairs for several medical device companies. Harvey lends his experience interfacing with FDA to assist ACG clients with comprehensive product release to market—from turnkey submissions to new device review and risks analysis for investment groups.

Bill T.

Bill’s service with the FDA gives ACG clients first-hand insights into inspections of medical device, pharmaceutical, bioresearch (GLP and GCP), biologics and food facilities. During his tenure with FDA, he conducted international medical device and pharmaceutical inspections in 18 countries. Prior to his work at FDA, Bill worked for major industry manufacturers and performed domestic and off-shore GMP audits of pharmaceutical and medical device operations, including all dosage forms, APIs, biologics, clinical supplies and sterile devices. His client engagements for ACG include working with multi-disciplinary project teams to prepare and coordinate agency inspections as well as facility renovations, equipment upgrades, PAI preparations and GMP issues.

Charles R.

Charles brings extensive clinical research expertise to ACG, gained in key management roles at sponsors, CROs and research sites for medical device and pharmaceutical submissions. His experience runs the full gamut of designing and managing clinical trial operations for Phase I to IV clinical pharmaceutical and device research–from patient recruitment to authoring and monitoring protocols to data capture, documentation and reporting to quality assurance—all in accordance with company-specific SOPs, FDA regulations, GCP and ICH guidelines. He has managed multiple studies at contract sites throughout North and South America, Eastern and Western Europe, India, Russia, China, Australia and Africa.