“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 in our journey towards excellence. We valued their work ethics in working long hours, their continuous availability to answer our questions and their attention to detail with in-depth explanations of how and why we needed to do things a certain way. Finally, a positive attitude and a passion for this work really came through in their interaction with other people. Most importantly, the contributions have delivered against our objectives of having more GMP compliant documents and processes.”
“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 were properly understood and implemented. I found The FDA Group to be particularly well-matched for the needs of our small operation, as they took pains to thoroughly understand the details of our existing processes and to reshape these in a way that satisfied the necessary requirements while minimizing the impact to the existing workflow. Their intimate familiarity with the many requirements made our exchanges efficient, as they could quickly steer the discussions towards providing effective solutions without pausing to research the details of the regulations. Their experience as a trainer/teacher for lead auditors facilitated our discussions, as they presented information in a clear and uncomplicated way, often supporting it with varieties of the materials and practical examples."
“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 such as recall management and 483 responses, The FDA Group has a pool of consultants to pull from that can assist you both expeditiously and professionally.”
“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 done for you.”
“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.”
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