"Just a quick note to thank you for the timely and thorough assistance you and your staff provided us recently. We especially appreciated your advice on regulatory strategies and suggestions for responses. I am sure this is true for most of your clients, but when we need help, we need it now! Your team never fails to recognize our priorities. Despite the other commitments your firm surely must have, AccuReg has always responded to our needs as if we are your only client."

"Thank you for the excellent job you and your staff did in conducting validity assessments ... I want to complement you and your staff for keeping all of your commitments to complete each individual report on time. The completion of the reports on time was very important to FDA, and therefore, to our success in keeping our products on the market...."

"Thank you for your outstanding assistance in the preparation and submission of the 510(k) ... Your staff is to be recommended for their attention to detail, and therefore their quality of work. I am very pleased with the outcome of our relationship - successful clearance of the submitted 510(k), and the guidance provided during this endeavor that allowed for a successful GMP audit."

"I would like to take this opportunity to sincerely thank you for the quality and timeliness of the gap analysis ... You succeeded where others have failed in working with the technicians at the lab, teaching them along the way, while remaining sensitive to their needs and concerns. Your clear, in-depth report is a reflection of your excellent knowledge and expertise in the field of software systems validation."

"I would like to take this opportunity to thank you and your staff for years of excellent regulatory, compliance and technical guidance and support. As a result of your efforts, [our company] has developed a firm commitment to quality, as demonstrated by our most recent FDA inspection. As you are aware, that occasion resulted in only one minor citation on our Form 483."

"Your recommendations regarding clinical development plans, FDA issues, IND reviews, strategic planning for FDA meetings, 510(k) reviews and GMP issues for the manufacturer of both the radiolabeled monoclonal antibody and gamma-detecting probe have been invaluable."

"As you know, we have used the services of AccuReg to perform our semi-yearly internal GMP audits since the inception of [our company]. Due to the excellent recommendations of AccuReg and our willingness to make changes and improve our GMP system, we have always felt that we have done a good job meeting the requirements of the FDA's GMPs. In January of this year, we were inspected by the FDA ... The inspection lasted four days and covered all aspects of the GMP. We are proud to say that we received no Form 483 comments from the inspection ... We feel that AccuReg is directly responsible for this excellent result, and we look forward to working with you in the future."

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