Regulatory requirements extend beyond design and development, manufacturing, and distribution processes. Product labeling grasp to specific standards across many regulated industries including medical devices, cosmetics, drugs, dietary supplements, etc. The U.S. Food and Drug Administration recently issue numerous warning letters for misbranded or “adulterated” products marketed in these industries. The FDA regularly reviews websites and product labeling for misleading or unsupported claims. Our consulting team has expertise in the regulatory requirements covering FDA regulations in the United States, requirements for labeling in the European Union under the medical device directives, as well as those covered by the Canadian Medical Device Regulations, TGA in Australia and Medsafe in New Zealand. It is pleasing for us to answer any questions related to labeling and marketing requirements for medical devices, cosmetics, dietary supplements, or OTC drugs. Our team is capable of providing a detailed review of the regulations and how they may apply to your products.

Additionally, our graphic design team is available for consultation on the design and development of your labeling and marketing materials. Our expertise includes product label design, user manual layout and organization, marketing brochure and newsletter development. Our designers work directly with our regulatory consultants to be sure that the applicable regulatory requirements have been addressed to provide seamless product marketing materials. Please contact our office to request a project quote or consultation.