EXPERIENCED AND SUCCESSFUL IN CGMP COMPLIANCE

Kaufman Flynn Consulting Services, LLC

Kaufman Flynn Consulting Service LLC (KFCS) provides regulatory and compliance services to the pharmaceutical industry. For over 30 years, we have helped companies resolve compliance problems, and to develop efficient and effective strategies for submission and approval of drugs. We serve clients including pharmaceutical and dietary supplement companies in the U.S, China, India, as well as other countries in Asia.

Our experienced team of consultants work with you to develop regulatory strategies and submissions; and remediate, maintain and improve regulatory compliance. Though much of our work is project-based, for some clients, we assume all regulatory responsibilities for a fixed monthly fee as a part of our Outsourced Regulatory Affairs (ORA) program.

KFCS’s pharmaceutical consultants understand the value of your product pipeline and work with you to develop regulatory strategies that optimize likelihood of approval, minimize cost and increase speed to market. Our experienced FDA compliance consultants who make up our practice each have at least 10 years' experience covering such areas as compliance, QA, QC, Manufacturing and have successfully resolved data integrity issues for companies that have either been placed on Import Alert or have received Warning Letters.

Over the years we have developed a simple approach to our work that guides each of our projects. We are driven to create successful regulatory outcomes that benefit the client and society - on time and within budget.

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