About FDA Compliance Group

At FDA Compliance Group, our global mission is to partner with our clients to achieve the highest regulatory and quality standards in the industry.

Our goal is to provide regulatory and quality guidance while representing the best interests of our clients.

Our vision is to help our clients deliver the highest quality FDA-compliant products to their customer base worldwide.

Your FDA Compliance Partner

We are FDA Compliance Group, an FDA consulting firm of highly qualified and experienced former US Food & Drug Administration investigators, compliance officers, and industry experts. Our consulting services help companies prevent and solve FDA regulatory and quality compliance problems.

We work closely with clinical, dietary supplement, medical device, pharmaceutical/OTC, cosmetics, biologics, cannabis/hemp/CBD, food/FSMA, tobacco and veterinary companies on all aspects of FDA compliance.

We also provide FDA technical expertise to law firms that work with FDA and we specialize in due diligence assessments for your merger and acquisition needs.

Our Team of Former FDA Experts

Our FDA consultants have served as FDA investigators, FDA compliance officers, CDRH, CFSAN and CDER executives. Our team is built around professionals who have held positions as Vice Presidents, Directors and Managers of international and US-based FDA-regulated companies.

This unique combination of Agency and industry experience gives us an in-depth understanding of the many challenges companies face as they balance regulatory and quality requirements.

We will work closely with your management team to target your needs throughout the entire FDA compliance process and provide practical, actionable solutions.

Flexible Compliance Support Solutions

In addition to our FDA consulting services, we can provide full-time or part-time consultants, as contracted management, to serve as your regulatory director, quality assurance manager, laboratory manager, complaint coordinator, MDR submission expert and similar roles. This gives companies access to well-trained external expertise and resources, without the overhead of hiring full-time employees.

From Registration to Remediation

FDA Compliance Group offers comprehensive services covering FDA registration, regulatory strategy, training, labeling/claims, auditing/gap assessments, and quality system implementation. Our expert services also include FDA inspection preparation, recalls, MDR, adverse event reporting, and FDA 483 & Warning Letter remediation.

From preparation of submissions such as GRAS and NDI's, 510k/PMA, and FSMA/FSVP to expert witness support and due diligence assessments, we provide the knowledge and experience your company needs for cost-effective, timely FDA compliance.

For more information on FDA consulting services or to schedule a consultation, please contact us today.