Profesional Services

What We Offer

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

Our Philosophy

ACG’s demonstrated ability to get things done is based on developing a hands-on partnership with our clients to ensure the transfer of knowledge so they become self-sustaining--educated and owning the final product. We pride ourselves on teaching our clients what we know: how to apply the pertinent regulations to technologies, to comply with the law, and to assess and understand risks. We utilize the same partnered approach in our relationships with agencies.

ACG consultants add expertise in areas including: product development; chemical engineering in sterile/non-sterile solutions; regulatory compliance with EPA and OSHA; manufacturing processes and procedures; research and development clinical study protocols; clinical trials management; adverse event evaluation; budgeting; work scheduling; technical trouble-shooting; manufacturing management training; supplier/vendor facility audits; labeling and marketing literature; and more. Our strong network of contacts also includes FDA attorneys.