FDA COMPLIANCE

FDA COMPLIANCE

Our firm specializes in providing solutions that help client organizations comply with FDA regulations. We offer a wide variety of FDA compliance services to all types of Life Science organizations that are regulated by the FDA in the United States and internationally. We are uniquely positioned to provide support for companies of all sizes, from start-ups to multi-national corporations.

EMMA International Consulting Group is considered the leading consulting firm for all FDA compliance matters. In fact, we have been selected among the top 25 “Most Recommended Compliance Service Providers” in the United States for 2016 & 2017 consecutively.

Our primary consulting services for FDA compliance include:

•    483 responses
•    Warning Letter responses
•    Remediation strategies
•    Labeling and website reviews
•    Audits and gap analyses
•    Mock FDA inspections
•    Regulatory submissions

Why choose our firm for your FDA compliance needs? We have the knowledge and bandwidth to support any size project, large or small, across the Life Sciences industry. Our team of seasoned professionals will help you by providing FDA with efficient and timely submissions of Warning Letter and/or 483 responses, thereby having your company avoid any negative set-backs in developing your product. Our consultants are considered subject matter experts as pertains to how to respond to FDA Warning Letters and/or 483s.

When you work with EMMA International, you can eliminate any worry about your compliance status.