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.

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 NGPs  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 and product launch, they will ensure all applicable aspects are covered for your marketing application. 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 dossier. We look to thoroughly review all of your supporting documentation to advise of any potential issues that may arise during regulatory agency assessment as well as provide you with suitable actions for resolution.

Operational Delivery 

We can support you on the delivery of scientific content in Analytical Chemistry and Product Safety for inclusion in your regulatory dossier to ensure your current and future products are safe, compliant, and commercially successful.

Post Marketing Surveillance 

We can provide you with subject matter expert support to execute your Post Marketing Surveillance plan for the lifetime of the product, including early product inception/ideation during New Product Development (NPD). Our team of highly experienced scientists, regulatory experts and scientific consultants have the necessary knowledge to support and navigate the relevant mandatory programme.

CE Marking

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 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 NGP products to market.

Resources

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Complete Service for NGPS

Leaflet

Download our brochure for an overview of our comprehensive services to support the NGPS industry from regulatory submission to maintaining compliance.
Booklet - Testing Requirements of TPD

Testing Requirements of TPD

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.
keller and heckman

Event Coverage—Keller and Heckman

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.

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