EIT Health's Venture Centre of Excellence Names ProductLife Group as Privileged Partner for Regulatory & Compliance

The ambitious EU initiative has already secured 2 billion euros of co-investment capabilities and has supported 60 innovative Biotech,Medtech & digital health start-ups to get to market or expand into new territories.

EIT Health,co-operator of the Venture Centre of Excellence alongside the European Investment Fund (EIF),has named ProductLife Group the exclusive Privileged Partner for Regulatory and Compliance to help expedite the navigation of regulatory barriers,thanks to its extensive Healthtech experience & trusted status as an existing EIT Health partner.

ProductLife Group's intervention will ensure young,ambitious startups are in good shape for regulatory approval,de-risking their path to market & making them a safer bet for VC and corporate backers.

PARIS,Nov. 8,2022 --ProductLife Group (PLG),a specialist provider of regulatory and compliance services for the life sciences industry,has announced its status as the exclusive Privileged Partner for Regulatory & Compliance services of the Venture Centre of Excellence (VCoE). EIT Health will recommend PLG to those early-stage Biotech,MedTech and digital health start-ups requiring support from a regulatory perspective to accelerate their journey to market thanks to the VCoE programme.

The role of the VCoE is to increase and accelerate market opportunities for early-stage biotech,MedTech and digital health start-ups across Europe,by matching these young companies with the funding,professional services expertise and contacts they need. The wider aim is to make Europe a more attractive and lucrative market for a new generation of life sciences trailblazers,whether they are entering the market for the first time or looking to expand their activities to other countries across the continent.

When the European Commission announced its EUR 150m anchor investment into the programme in October 2020,it set out an ambition to facilitate 2 billion euros in investment and bring 200 fledgling start-ups to market over a period of 15 years. That investment level has already been achieved,with more than 60 start-ups to date benefitting from funding mobilised thanks to the programme,stemming from its selected VC funds and Corporate members having joined the initiative,with further such entities due to join in the weeks and months ahead.

As well as putting promising early-stage start-ups together with crucial funding,EIT Health's VCoE aims to build their market readiness,through valuable contacts and access to professional services. Since many of these small scientific teams have come out of university labs,they may bring valuable innovations to the market when they'll get support for the administrative aspects of their project. The VCoE's role is also to propose this support to the start-ups and ease their path to market.

PLG's intervention,when taken up,will ensure that promising young,ambitious start-up teams are in good shape for regulatory approval,de-risking their path to market & making them a safer bet for VC and corporate backers.

One start-up that has already taken up PLG's services through the partnership is Sensius - clinical evaluation gap analysis in the context of medical devices

EIT Health's selection of PLG as its exclusive Privileged Partner for Regulatory & Compliance services in the VCoE is a testament to PLG's proven track record in helping emerging Biotech and other innovative life sciences start-ups navigate regulatory complexity. PLG is a long-standing trusted partner of EIT Health.

Commenting on the new collaboration between VCoE and PLG,Isaac Middelmann,Head of Access to Finance for EIT Health InvestHealth: "This is a very exciting development,which will help cement the opportunities we have set out for promising early-stage start-ups targeting the latest challenges and opportunities at the cutting edge of life sciences. Access to trusted professional services and expertise is as critical to these start-ups as a financial investment,as the two go hand in hand."

Jean-Marc Bourez,EIT Health Services & Investment Managing Director,added: "Our corporate and VC members are keen to support these young,innovative and ambitious companies,and it helps enormously here if the teams coming forward have already been vetted and guided through the relevant regulatory requirements to bring their therapies to market in Europe. PLG is ideally placed to help with that,with its rich knowledge of the regulatory and cultural context in each European market,and its detailed understanding of how reimbursement works in each country,as well as the complex respective requirements around clinical trials."

"We are honoured to be called upon in this way,which fits perfectly with our own strategic aim to champion the next generation of European life sciences leaders," said Xavier Duburcq,PLG'sCEO. "This is all about levelling up the opportunity for aspiring start-ups in Europe,compared with other important geographic markets such as North America and the Asia-Pacific region."

Gabrièle Breda,Head of Innovation at PLG,added: "Nurturing biotech,MedTech and digital health innovation is a core part of our strategy. So it is with great pride that we are embracing this prestigious partnership and,through it,this invaluable opportunity to help young,ambitious companies navigate the market complexities effectively and efficiently so that they can realise their potential without delay."

Both EIT's VCoE and PLG will be taking an active part in the forthcoming Medica fair trade on November 14-17.

About EIT Health

EIT Health is a network of best-in-class health innovators backed by the EU. We collaborate across borders to deliver new solutions that can enable European citizens to live longer,healthier lives. As Europeans tackle the challenge of increasing chronic diseases and multi-morbidity and seek to realise the opportunities that technology offers to move beyond conventional approaches to treatment,prevention and healthy lifestyles,we need thought leaders,innovators and efficient ways to bring innovative healthcare solutions to market. EIT Health addresses these needs. We connect all relevant healthcare players across European borders – making sure to include all sides of the "knowledge triangle",so that innovation can happen at the intersection of research,education and business for the benefit of citizens.

About the Venture Centre of Excellence

Through the VCoE,members join an exclusive community of selected venture capital funds and private investors thereby boosting the flow of investment directed towards European life science start-ups,SMEs,and Small Mid-Caps by matching fund managers with pharma corporates and other interested strategic investors. The VCoE addresses the specific interest of its members to access open innovation,by increasing their co-investment capabilities and opportunities for strategic collaborations in highly innovative European life science start-ups. Programme members will be able to share these start-ups themselves,and EIT Health will also vet start-ups from its network to present to members,including thanks to an exclusive artificial intelligence-based platform developed by Skopai,the VCoE's technical partner.

About ProductLife Group (PLG)

ProductLife Group's mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.

Since almost 30 years,PLG supports clients through the entire product life cycle,combining local expertise with global reach spanning more than 150 countries. It provides consulting and outsourcing services in the areas of regulatory affairs,quality and compliance,market access (pricing & reimbursement),vigilances and medical information,covering both established products and innovative therapeutics & diagnostics.

With a goal of continuously improving the value delivered to people and customers,PLG is committed to long-term partnership,innovation,flexibility,and cost efficiency.

For more information,visit productlifegroup.com

Contact

Fabrice Galzin

ProductLife Group Head of Marketing

+33 675 349 606

fgalzin@productlife-group.com