Our Regulatory Services support companies in the nicotine industry to achieve their regulatory compliance goals in bringing their NGPs to market in an effective and efficient manner. With a background in maintaining compliance with pharmaceutical regulation and our track record of supporting the first ENDS product to obtain a medicinal product license in the UK, we are best placed in advising our clients regarding UK, EU and US regulations.
Electronic Nicotine Delivery Systems (ENDS) Products: Our team of experts can provide advice and support for CE marking certification. Although not a requirement for the Tobacco Product Directive (TPD) in which a ENDS product is registered for consumer use, if a device is intended to be used as a nicotine replacement therapy to aid smoking cessation, it will need to be submitted in Europe as a Medicinal Product application and the device will also be required to conform with the requirements of the Medical Devices Regulation (MDR). Devices which are classified as IIa or higher will need their technical documentation to be assessed by a Notified Body, after which, if successfully certificated, CE marking is granted.
We believe in nurturing collaborative relationships with our clients, and we strategically align our services with their business goals. We are here to provide you more than test results, and we have the experience to help you achieve regulatory compliance in bringing new NGP products to market.
LeafletDownload our brochure for an overview of our comprehensive services to support the NGPS industry from regulatory submission to maintaining compliance.
White PaperDownload our whitepaper to read an overview of the Tobacco Products Directive requirements and get the straightforward answers you're looking for when it comes to TPD analysis.
Read our blog to get an overview of the Keller and Heckman Tobacco Law Symposium. Here we learned about the latest industry trends and legislation in the regulation of electronic nicotine delivery systems.