Specialists in Regulatory Affairs and Clinical Studies for Medical Devices and Biotechnology
Mullis & Associates, Inc. is a regulatory affairs and clinical studies consulting firm focusing on medical devices and biotechnology. The firm's senior management has 23+ years of corporate experience in both small and large US and European based companies. Mullis & Associates, Inc. can provide your company with management experience and technical expertise to successfully bring your new products through the FDA regulatory process.
Our regulatory affairs, quality and clinical studies expertise includes, but is not limited to, products in the areas of cardiology, urology, gastrointestinal, oncology, radiology, orthopedic and surgical devices. We have worked with varied technologies including pacemakers, leads, vascular and biliary stents, vascular grafts, ports, implantable cardioverter-defibrillators, infusion pumps surgical irrigation devices, heart catheters, urological catheters and instruments, surgeon's gloves, antimicrobial coating, bulking agents for urinary incontinence, hernia repair products, polymer and hydrophilic coatings, endoscopes, laser fibers, invitro diagnostics, drugs, drug delivery systems, OTC drugs, and cells and tissue for human implantation.
Our firm will work with your company from initial product concept to the point when the product is fully marketed. Whether you are a start-up company preparing an initial regulatory strategy for the a first product or an established firm needing incremental resources for a critical project, Mullis & Associates, Inc. can provide creative and cost effective solutions. Our expertise is available to you.