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Our Regulatory Services support ENDS companies in achieving their regulatory compliance goals in bringing their products to market in a effective and efficient manner. With a background in maintaining compliance with pharmaceutical regulation and our track record of support the first ENDS product to obtain a medicinal product license in the UK, we are best placed in advising our clients to UK, EU and US regulations.

Consultancy

We work with you to develop a strategy aligned with your business requirements to maximise delivery with minimal cost. Our team has the expertise to provide you with reliable advice on the compliant regulatory submission of ENDS products within the UK, EU and US.

Project Management

A dedicated Project Manager will work with you to map out a plan of action. From supplier assessment to CE marking, they will ensure all applicable aspects are covered for your submission. In addition, they will maintain regular meetings with you to communicate progress against deadlines

Compilation and Filing

Our team will manage and collate relevant data for your regulatory submission. We look to thoroughly review all of your supporting documentation to advise of any potential issues that may arise during assessment as well as provide you with suitable actions for resolution.

We work with you to develop and deliver regulatory strategies that meet your business goals.

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Why our clients work with us

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 ENDS products to market.

Resources

Brochure

Download our brochure for an overview of our comprehensive services to support the ENDS industry from regulatory submission to maintaining compliance.

White Paper

Download 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.

Blog

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.