ADACT Medical is an independent medical consulting company based in the UK and is Europe’s largest compliance agency. Our founder and Chief Regulatory Officer is Damien Bové, BSc (Sci. Hons), MSc (Sci. Open), ICR. He heads up a team of experts who have an in-depth knowledge of the vaping industry and can help you to grow your business:
- Over 20 years experience of pharmaceutical, biotechnology, herbal medicine and medical device compliance and development work.
- Successfully presented toxicology assessments on e-cigarettes to the MHRA to support development planning.
- Worked on regulatory programmes to support electronic cigarettes since 2006 when e-cigarettes were first introduced into the UK.
- Consulted on five MHRA regulatory programmes for the medical registration of inhaled nicotine products including electronic cigarettes.
- BSI Electronic Cigarettes and E-liquids Committee Member – helping to set future standards.
- Registered Member of the Institute of Clinical Research (ICR).
- UKVIA Member.
Our Chief Regulatory Officer’s expertise
ADACT’s founder and Chief Regulatory Compliance Officer is Damien Bové, BSc (Sci. Hons), MSc (Sci. Open), ICR. Damien studied at the University of Bradford and earned a Bachelor of Science degree with honours in Pharmaceutical Management. He went on to complete a Master of Science degree in the Frontiers of Medical Science at the Open University.
Damien first cut his teeth as a pharmaceutical technician, then as an academic research manager at SmithKline Beecham. From there he went onto the Consultancy Division for Covance (Global Contract Research Organisation) where he worked alongside Anthony Lockett, CEO and Director of Biotaspheric Ltd, focusing on emergent product services, defining markets and regulatory development strategies for novel pharmaceutical and biotechnology products.
In 2004, as an independent consultant, Damien worked with regulatory agencies across the globe to fast-track products into MAN. He developed strategies and worked within the regulatory structures of the FDA, EMA, MHRA and Health Canada, amongst others. He also organised courses on The Regulations of First in MAN Clinical Trails and Business Planning for MedTech Entrepreneurs.
In January 2014, Damien became Director of the Innovation Centre at Charnwood Biomedical Campus, a centre for innovative life-science businesses looking for high-end laboratories and offices in the heart of England. Alongside this, Damien worked with Tom Chapman to develop Lifespray Sublingual Vitamin range and developed the first CBD vape product.
In 2014, the EU implemented the Tobacco Products Directive or TPD for short, which introduced new rules for the vaping industry from May 2016. Starting with a handful of customers, ADACT has grown into Europe’s largest compliance agency.
What we do
We offer expertise and support throughout the various testing stages of vaping manufacturing, from notification to marketing and pairing businesses up with distributors. We have over 320 customers and have:
- tested more than 23,136 products
- one and a half million + TPD presentations in Europe
- completed 750 + toxicology reports
- over 3,930 flavour concentrates in our system.
The services that we offer include:
- Specialist compliance services internationally for companies wishing to sell vaping products in the EU, including: CBD, devices, e-liquids, pods and short-fills, under TPD.
- US compliance services for e-cigarette products as required by the FDA under PMTA – deadline 11 May 2020.
- CBD testing in our ISO 17025 accredited lab.
- Heavy metals testing.
- Classification, labelling and packaging (CLP) advice.
- Branding and distribution advice to enable products to get to market.
- Creating NEW updated Safety Data Sheets (SDS) for risk assessments that comply with the change to CLP regulations in December 2018. If companies have sheets that pre-date this, new ones will be required
- European Central Poisons Registrations – deadline 1 January 2021.
ADACT is not connected with any one particular supplier. We work closely with all the Flavour Houses who provide formulations, essential for completing TPD notifications.
We are here to help and guide you and your business through the process of ensuring your products comply with legislation. Call sales on +44(0)7980 599475, the office on +44(0) 1302 986088 or email email@example.com. We look forward to working with you in the future.
British Standards Institute (BSI)
Electronic and E-liquids Committee Member (Damien Bové, Chief Regulatory Officer)
The Electronic and E-liquids Committee of the British Standards Institute takes an advisory position in the governance and resilience of electronic cigarettes and related e-liquids, but has frequently set standards of best practice which the industry at large follows. The committee feeds into international standards and has a voting position on the International Organization for Standardization. This working group is made up of UK industry experts who frequently help to draft international standards in this rapidly evolving sector. Current members include; representatives from Ministry of HCLG, MHRA, IBTVA, London Fire Brigade, Consumer Rights and Protection Network and ADACT’s Chief Regulatory Officer, Damien Bové. The committee meets face to face twice a year in September and March but work throughout the year on a range of issues.