PMTAs | Arcus Compliance

Pre-market tobacco applications

In September 2020, the USA began to regulate its vape market, with the Food and Drug Administration (FDA) implementing the Premarket Tobacco Product Applications (PMTA). This applies to any vape product on, or entering, the US vape market.

After a number of client queries & requests, we have created our own bespoke PMTA guidance platform and since its launch, we have successfully submitted a number of projects to the regulator.

If your business is taking steps to enter the US market, you will need PMTA guidance. We have strategies in place to avoid paying the $1 million price tag charged by other consultancies. Let Arcus Compliance take the stress out of compliance & regulatory issues by managing this for you. Get in touch to discuss ways in which we can help create an effective PMTA strategy to meet your budget.

Contact us for more information.

If you’d like to read the latest information on PMTA Guidance check out our latest post here: A NEW ERA FOR PMTA REGULATIONS

Arcus Compliance have been a pleasure to work with right from the get go. Their team have helped us with many aspects from safety data sheet authoring, reviewing existing product notifications and ensuring that our packaging is fully compliant with the TPD and CLP requirements. However, the knowledge and services they offer expand way beyond what we have utilised to date, and we're looking forward to working with the team more in the future. Having a company like Arcus on board takes a lot of worry and stress out of making sure we are compliant with all of our products. No issue is too big or small for them and requests are handled quickly. If your company is looking for help with compliance you won't regret talking with Arcus and getting them on board - amazing customer care! Thanks guys!

Kev Russell

Lab Development Project Manager, The Ace of Vapez
We have a retained contract with Arcus Compliance, on an annual basis, to deal with all of our compliance requirements. We moved our Compliance function from in-house, to Arcus Compliance, over a year ago and we couldn’t be more pleased with how the relationship has worked out. The team are not just highly knowledgeable but they are also incredibly efficient. No request is ever a problem and they are very personable to boot. We would recommend Arcus to any vape company looking to outsource their Compliance needs.

Emma Logan

Managing Director, JAC Vapour
We used Arcus Compliance for a couple of our projects and we were very impressed with their services. Very quick and responsive, quality of their work is excellent and they have a very knowledgeable and professional team. With this in mind, we made the decision to opt for a retained service. Best move we made. They have taken all of the compliance headaches away from us, and we trust they have handled everything to the highest level. Excellent from A-Z.

Kyri Potamitis

Procurement Manager VAPE SUPPLIER
Eco Vape Ltd has been a client of Arcus for nearly 2 years. It was clear from the very start of our contract that an excellent customer service experience was the key driver for Arcus. The team are friendly, knowledgeable, and highly skilled. Their service is always 5 Stars! We remain very impressed with Arcus Compliance and look forward to a long partnership with them.

Brett Heaps

Managing Director, EcoVape Ltd
We’ve been working with Arcus for about 2 years. Initially, we engaged Arcus on project-based requirements, however, we have since migrated to retained client partnership. We’ve been very pleased with Arcus Compliance's service and they have assisted us in every single step in dealing with EU-TPD compliance requirements and ensuring our products are in total adherence. We are looking forward to a continued working relationship with Arcus as we grow our business and expand into other countries."

Ramin Warda

Managing Director at Vont AB Sweden
We have used Arcus Compliance for over a year now and throughout that year the Arcus staff have been paramount in handling our compliance needs. Through all our compliance requirements, Arcus have provided up to date advice, effective resolutions and a friendly service. We are grateful to have such reliable support for the future of our business and peace of mind our compliance is not a cause for concern.

Dan Perks

Production Manager at Zeus Juice UK
2 years of partnership with Arcus Compliance has taken the complications, stress and unclarity out of arduous regulatory compliance. The conveyance of compliance through all of its stages was highly convoluted. Through the team behind Arcus we can rest assured that we now cover all areas of compliance appertaining to our business, even in areas we did not know we were lacking. In a market where our compliance is developing and dynamic we need that solid guidance to instruct us to future proof our business model. They are easy to talk to and take the guess work out of compliance. Their dedication and attention to detail in our opinion makes them the only compliance company you can trust with your business and future.

Harry Owen

Managing Director at UK Aspire Vendor
We were working with Arcus for almost 2 years through our involvement with ASPIRE, as UK distributors. So when the time came for us to improve our internal regulatory affairs the decision to appoint Arcus as our retained partner, was a simple one. We are already under going an extensive improvement program in CORE COMPLIANCE, that will see our due diligence and documentary evidence increase immeasurably.

Ash Heaton

Director at ifancyone