Arkin Consulting Group, LLC.

What We Offer

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

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Arkin Consulting Group

Since 1994, Arkin Consulting Group (ACG) has been serving the U.S. and international medical device, pharma, biologics and veterinary product industries. We provide expert consulting in regulatory, quality assurance and clinical management. ACG adds value to compliance, submissions, engineering, auditing, training and other strategic regulatory issues through the years of experience and expertise dedicated to your team.

ACG is a full-service consulting firm whose senior professionals get involved in every account. We take the time to listen and learn because we are committed to building lasting relationships.

Clients gain confidence and skill from ACG because of our knowledge of and ability to combine science with business from a regulatory basis. We view ourselves not so much as the “experts” but educators so clients can sustain the processes and expertise gained from our association on their own.

Professional Services

ACG has been called upon to formulate master clinical plans and cGMPs for multi-national corporations bringing new medical products to market. We help clients respond quickly with a course of action that will regain compliance and resolve regulatory issues. Often, we are called upon to provide feedback on proposed regulatory approaches, design control, QA programs and clinical trials.

Expertise

ACG distinguishes itself from other consultants by the depth of experience and reputation we have in the industry and with regulatory agencies. Contact us for examples of projects we have completed that are similar in scope and nature to your needs.