Novex Innovations is a true CDMO (Contract Development/Manufacturing Organization) supporting our clients efforts in the commercialization of their products. Our areas of operation include: Biological Formulations Clinical Formulation Tissue Processing Bioengineered Tissue Active Pharmaceuticals Diagnostic Materials Medical Devices Development to Pre-Clinical to Commercial Regulatory Support Storage & Distribution & Order processing services. Scale-up optimization Product characterization Manufacturing through all phases of clinical trials Commercial modeling, manufacturing, and distribution Proof of concept Our clients range from single person operations to multinational companies. We provide process development, manufacturing, storage, and product distribution, all under cGMP procedures and policies. We operate cleanroom space at Class 1,000 and smaller scale spaces at Class 100, all for clinical and commercial manufacturing. Our Quality System is regularly monitored to the current ISO 13485 standards by BSI. Novex is also registered with the FDA. Our customers are both national and international and have a good understanding of other regulatory agencies as well. Customers have the option of storing their products at and having Novex ship on their behalf.