Regulatory Issues

No matter what market your products reach, chances are you’re encountering some level of regulatory oversight and the resulting hassles that arise from them. While these standards are valuable in protecting consumers, validating sustainability, or ensuring efficacy, they often place a tough burden on OEMs.

From a material perspective, we can help you make your way through regulatory complexities by leveraging our Product Stewardship program. Our internal Good Manufacturing Practices (GMP) guidelines govern the manufacture of intermediate products for our customer’s use in making food, drug and medical (FDM) final product applications. And many of our offerings comply with the current alphabet soup of regulatory requirements, from FDA to RoHS, USP to ISP, CPSIA to Prop 65. These include ISO pre-certified colorants; FDA-compliant materials from engineering thermoplastics and elastomers to vinyl, styrenics and olefins; RoHS and REACH compliant materials; and much more.

Manufacturing medical devices? We support your Device Master File submission for healthcare materials by developing and maintaining U.S. FDA Drug Master Files and Medical Application Files.