Analysis & Regulatory Support 

Thanks to our long-term experience in working with specialty polymers for a wide range of applications, we can offer you valuable assistance in building the regulatory (technical) files for your product. We can determine which requirements relating to e.g. safety are related to the material and are relevant for your product. Because we understand the physical and chemical properties of the material, we are also able to advise you on the tests relevant to your product. This way, unnecessary tests and thus unnecessary costs, are avoided. In addition, we can assist you in interpreting test results by other parties and in deciding the submission level of the regulatory file. We can also provide advise on protocols and regulations for your production environment that ensure proper quality control of the product.

For instance, for medical devices PolyVation performs biocompatibility research that may include:

• Review
• Plan and/or protocol development
• Rationales
• Physico-chemical tests (GLP, ISO 10933)
• Biological tests (GLP, ISO 10933 - outsourced to qualified labs)