Why do our clients choose to work with us?
There are many reasons why our clients choose us over our competitors. Here are just some:
> We are independent experts
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).
> Our experience in regulatory affairs
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.
Background in pharmaceutical 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.
E-cigarette regulatory experience
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 on going 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 minimise compliance costs
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 minimise 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 wih a ‘best practice’ and ways of working in all aspects of vape compliance.
The regulations, manufacturing standards and testing standards shall develop overtime, and as it does, we are committed to providing our clients with this information and recommendations on the best way forward.
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