Drug Compliance

Drug Compliance

“We were thrilled at having the opportunity to work with The FDA Group, LLC over the last eight months. Their knowledge, expertise, experience, and professionalism in the OTC drug GMP requirements were heavily relied upon to upgrade our documents, processes and thinking surrounding compliance practices and was extremely valuable... ”

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Device Compliance

Device Compliance

“I’ve had the pleasure of working with The FDA Group on Quality System matters as they pertain to the FDA. The FDA Group was brought in to perform a thorough gap analysis in several areas of our quality system, to suggest mitigations for these gaps, and to help with Quality System training to ensure that the proposed mitigations…”

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Drug Regulatory

Drug Regulatory

“I highly recommend contacting The FDA Group, LLC if your company is in need of regulatory consulting. They have successfully matched the right consultant to the right issue for our business many times. From day-to-day Regulatory Affairs questions and training to significant issues, The FDA Group has a pool of consultants to pull from that can assist you..”

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Device Regulatory

Device Regulatory

“To all who are considering doing business with The FDA Group, we would recommend them with no hesitation. The FDA Group is very professional and does business promptly. They responded to us at all hours of the day or night if we were trying to resolve a situation and move ahead. We know you will be satisfied with the project…”

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Expert Witness

Expert Witness

“I am happy to inform you that this case has now settled. I believe that your contribution and expertise helped to convince the defense that settlement would be the most appropriate means of resolving this matter. I appreciate all the work, effort and guidance that you have given me in this case. Again, I enjoyed working with you.”