Lindsey Regulatory Affairs Consulting, LLC (DBA, LRA Consulting) strives to meet the needs of the client in every way. We are committed to the success of your products and strive to help you develop and implement regulatory and quality solutions catered to your needs. Our team of consultants bring several years of combined experience in Regulatory Affairs, Quality Assurance, and Clinical Affairs with a proven track record of executing global strategy techniques in a timely and cost efficient manner.
The LRA Consulting team has years of experience working with regulatory bodies around the world such as the US FDA, EU Competent Authorities and Notified Bodies, Brazil ANVISA, Mexico COFEPRIS, and Authorized Representatives. With our experience, we are well equipped to prepare and submit regulatory applications, help interpret regulations, and handle all regulatory interactions all over the world.
We have experience with many clinical areas including cardiology, gastroenterology, orthopaedics, surgical instruments, and intraocular lenses. Let our team of experts assist your company with bringing new technologies to the market as well as provide specialized regulatory knowledge that will also maintain your current product portfolio’s compliance to industry standards.