There are many reasons why our clients choose us over our competitors. Here are just some:
We are a fully independent consultancy – we have no ties with e-liquid, device, tobacco, or pharmaceutical manufacturers or trade associations. We do not sell or manufacture our own brand of products or operate OEM/ODM (re-branding).
Tobacco and e-cigarette regulation in the US, EU, and globally, is broadly based on pharmaceutical regulation. The requirements are essentially the same – just less strict. Our extensive knowledge and experience with the medicine regulatory requirements underpins our expertise in e-cigarette and tobacco product regulation.
We have worked with some of the largest pharmaceutical companies in the world including GlaxoSmithKline, Wyeth (now part of Pfizer), and Apotex. We have obtained and maintained the medical product licences (like the FDA’s PMTA but for medicines) of hundreds of different types of products from inhalers, tablets, and solutions in many territories including EU, U.S, Central and South America, and Africa.
We have been helping retailers, distributors, and manufacturers around the world understand the emerging e-cig regulations for over 3 years. In that time, we have helped our clients with a range of activities: prepare and submit notifications, arrange emissions testing, prepare TPD compliant packaging, advise on developing manufacturing standards, resolve notification issues/disputes, understand FDA e-cig regulations and general regulatory enquiries.
We have worked with a variety of vape businesses from small UK and international retailers to large well-established device manufacturers, e-liquid manufacturers, and distributors. We continue to provide ongoing regulatory support to many of them.
We believe our fees we charge are reasonable and affordable. We offer payment plans that enable our clients to spread the cost of our services.
We have a thorough understanding of the regulatory requirements – we understand what is required and what is not. We will never try to sell you notification, toxicology, or analytical testing services where it is not required. One of our key duties is to keep compliance costs low. We also work closely with our clients to minimize the impact on business of new and emerging regulations, which, in turn, helps our clients to save money.
Given that official guidance on e-cigarette regulation is lacking and there are no testing standards, we offer our clients with a ‘best practice’ and ways of working in all aspects of vape compliance.
The regulations, manufacturing standards, and testing standards shall develop over time, and as it does, we are committed to providing our clients with this information and recommendations on the best way forward.
We are a London-based regulatory affairs consultancy providing services to the e-cigarette, cosmetic, biocide, pharmaceutical and medical device industry. We help e-cigarette companies comply with the Tobacco Products Directive and pharmaceutical companies obtain and maintain medical product licences. We also offer UKAS accredited biocide and analytical testing services.