We specialize in helping organizations comply with FDA regulations, and offer 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 able to support 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 were selected among the top 25 “Most Recommended Compliance Service Providers” in the United States for 2016 & 2017 consecutively.
Our FDA compliance services 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 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, letting your company avoid any negative set-backs in developing your product. Our consultants are subject matter experts in FDA Warning Letters and/or 483s.
When you work with EMMA International, you can eliminate any worry about your compliance status.