Drug Regulatory

Drug Regulatory Success Stories

“We engaged The FDA Group to assist with quality system improvements in the wake of a US FDA inspection at one of our manufacturing facilities in China resulting in the issuance of a Form 483.  The FDA Group worked with us to tailor their assigned team so that the right skills and experience were represented.  The team traveled twice to the site, first in June 2019 within two weeks of first contact for a first round of recommendations and then again in September 2019 for a follow-up assessment after implementation of many of the improvements. Reports were issued promptly after both visits with clear, pragmatic recommendations based on direct observation and clear reasoning. I was impressed with the knowledge, productivity, and professionalism of all 4 team members. I recommend The FDA Group to any pharma manufacturing organization seeking to respond to audit observations or otherwise improve their quality system.”

“The FDA Group is an excellent resource. The consultants we worked with on a variety of CMC and quality topics were very knowledgeable, professional, and approachable – a pleasure to work with to formulate solutions to our questions.  I wouldn’t hesitate to engage with them again for projects in all phases of development and recommend them highly.“

“The FDA Group is very responsive to our needs. We requested a very specific consultant that had experience with language with our product.  We wanted to make sure that we were compliance with FDA guidelines. The FDA Group was able to provide alternative wording so we could still communicate our message to our consumers while not making unapproved claims.   We were given feedback on our brochure content as well as unsolicited testimonials from customers.  We had a high sense of urgency to turn around our marketing support and The FDA Group works at the same pace we do!”

“The FDA Group is very responsive to our needs. We requested a very specific consultant that had experience with language with our product.  We wanted to make sure that we were compliance with FDA guidelines.The FDA Group was able to provide alternative wording so we could still communicate our message to our consumers while not making unapproved claims.   We were given feedback on our brochure content as well as unsolicited testimonials from customers. We had a high sense of urgency to turn around our marketing support and The FDA Group works at the same pace we do!”

“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.”

“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 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.”