"We recently completed a small auditing project with The FDA Group. All interactions were very positive. We will continue to look to their support on our programs going forward."

"The FDA Group is a consulting company I would refer to any colleague. They make the scheduling and PO process extremely easy and give you a variety of consulting candidates to choose who’s right for you. The consultant they sent over was extremely knowledgeable in the industry and gave us some excellent advice. I would be happy to use them again."

“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.

In addition to their wide breadth of knowledge, I found them to be very professional and respectful in their demeanor, mindful of the company’s needs and resources, and flexible in working around our schedule to accommodate our needs. They communicated clearly, were well-organized and were very accessible. On a personal note I found our exchanges to pleasurable and insightful.

Based on my experience with The FDA Group, I have no reservations in recommending them for matters related to Quality System development, implementation, compliance, and maintenance. Given the opportunity I would gladly work with The FDA Group on future projects.”

“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.”

“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 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.”

“It is my pleasure to communicate to you how successful and positive our engagement has been with your organization. Our company, as a holder of FDA Registrations with unique credentials as a joint Commission Accredited Ambulatory Telehealth Provider and as an Approved Center for Medicare and Medicaid (CMS) Independent Diagnostic Testing Facility, were faced with improving a very complex Quality System. Specifically, our company needed support to address a FDA Warning Letter. The FDA Group’s guidance, professional interaction, and expertise meet this large need.

The FDA Group provided our organization with a detailed GMP audit and identified our areas of strength, but most importance the areas requiring improvement to ensure that all gaps and deficiencies were addressed immediately and in the future. The assigned expert contractor’s vast experience with the FDA regulations and Quality gave our organization new insights into how we could be voluntary compliant with all standards, while at the same time balancing the needs of the company’s clients and our other regulatory agencies demands.

I am pleased to report that today we believe that our organization’s Quality System is greatly improved and most importantly we believe that the FDA is completely satisfied that we have addressed all issues that lead to the company receiving a warning letter. It would be my pleasure to provide a reference and recommend your organization at any time.”

“I wanted to let you know how impressed we are with The FDA Group. Your knowledge, thoroughness, and ability to work with our staff was very impressive. You were extremely informative and well received by our all of our staff. We really appreciate your effort to coordinate the visit. This is the type of interaction that builds a strong relationship and your organization is on the top of our referral list. We look forward to the report as well as a continued relationship with The FDA Group.”

“The FDA Group worked with us on a failure investigation involving pyrogens failure. Their consultants led the team that was instrumental in breaking down the different operations of the process and going through each one of the processes meticulously to identify the root causes of multiple problem areas. Once the sources were determined, they developed a strategy to reduce the exposure of pyrogens within the process. This reduction included:

• Enhanced the cleaning procedures and test methods to remove pyrogens from the processing equipment
• Updating FMEA’s
• Training of Operators on the entire process (Operator Certification)
• Pulling samples at each stage of the process to identify that step was the cause for the failure for the lot
• Developed checks and balances to more effectively supervise and implement cleaning procedures
• Multiple monitoring steps to look for trends

Before this thorough investigation was done, we had scrapped out over $500,000 worth of material due to this failure. Once we were able to put the corrective actions in place and educate the staff, these failures were eliminated.”

“Working with The FDA Group is a learning experience for all involved! We had them in twice for mock FDA Inspections. We not only learned more about compliance but also learned a lot about benchmarks and what is being observed in the best in class organizations. I highly recommend The FDA Group to any company that is serious about quality, regulatory and compliance!”

“The three of the folks who performed our work did a fantastic job and did what was asked of them. In fact, they did a bit more then what was required which will ultimately help the site in the long run. The site does appreciate their efforts. I would recommend them again for this type of work or something similar.”

“The FDA Group was able to support our urgent business need in a short period of time. What I thought would take weeks only took a few days. A qualified ex-FDA inspector that met our requirements was provided to our project team in just a few short days. The project had a successful outcome and the team was very happy with the results and support from the resource(s) provided by The FDA Group.”

“I wanted to personally thank you for The FDA Group consultant’s support and participation, as an external Subject Matter Expert and presenter during our annual training. We are still working on metrics for the event, however all feedback received so far has been totally positive. Our attendees were delighted with the topics and presentations from all of the presenters. It is our goal to combine technical and compliance training during these events and throughout the year to create and maintain a Compliance Mindset and Quality Culture that we can be proud of.”

“Thank you for your timeliness with deliverables. It was my pleasure to meet you and work with you.”

“Thank you for keeping your eyes open for new FDA guidance documents. That is always helpful.”

“Our FDA Group consultant helped our company understand the regulations surrounding manufacturing. We received assistance with writing cGMP-compliant Standard Operating Procedures customized for our operation, qualifying and auditing contract manufacturers and suppliers, and developing Quality Agreements. The training our consultant provided helped us to save money on hiring personnel with expertise in these areas. Our consultant was able to execute quality work in a timely manner.”