Our Clients are continually surprised at the speed and level of expertise we are able to mobilize to help solve their problems within Quality and Regulatory. Utilizing Neozene’s breadth of expertise, we are able to effectively diagnose and execute the appropriate solution in a cost effective manner. Whether it is outsourcing of an entire project or adding our Team to yours, Neozene will customize a solution to solve your Quality and Regulatory needs, large or small.
Our experts establish robust, ISO-13485 and FDA quality systems from scratch or upgrade the Quality System or subsystems you already have in place. This includes everything from brainstorming ideas, writing quality manuals, facilitating quality policy projects, initiating quality system infrastructure, and corporate-wide training. In addition, we represent a pool of quality auditors that can review your existing quality system in preparation of regulatory agency inspections, for ISO 13485 certification, or for annual quality requirements.
The Regulatory experts in Neozene can help your organization establish all processes necessary to meet all regulatory requirements. Whether these requirements are for regulatory submissions, licensure, general compliance, and training, our team of experts will efficiently and effectively establish or assist in establishing a regulatory infrastructure that will withstand scrutiny of any regulatory body in the world.