Meet Gabriele Breda, our innovation Director at PLG for an exclusive interview

Embark on our thrilling innovation journey at PLG with A Story of Innovation Series. At PLG, research and innovation are more than just a concept; they are one of our driving forces, shaping the future of healthcare.
Explore the challenges we encounter in the dynamic landscape of life sciences and how we proactively address them through cutting-edge research and collaboration.
At PLG Research and Innovation, we’re committed to empowering regulatory affairs experts and driving strategic innovation, ensuring our solutions meet the evolving needs of our clients and the industry as a whole. Follow us in this journey of discovery as we showcase groundbreaking examples of digital and AI innovations.
Watch our Story of Innovation

"ProductLife Group: the rise of a French champion in healthcare services", an interview by Les Echos Capital Finance

Find our more about PLG’s ambitions in this exclusive interview of Xavier Duburcq, CEO of ProductLife Group, and Fabrice Voituron, Managing Partner of 21 Invest France on the rise of ProductLife Group as a leading company in the Healthcare industry by Les Echos Capital Finance.
Learn about PLG's growth there

CTIS Transition: Time is running out!

Do you have trials ongoing in the EU? Are you struggling with the clock as the deadline for adhering to the Clinical Trials Regulation (CTR) is approaching quickly? Zwiers Regulatory Consultancy BV, part of ProductLife Group, can support you with the transition to the Clinal Trials Information System (CTIS).
Check out the full article

First report of the HoA working group "Food Supplements"

The European Heads of Food Safety Agencies’ Working Group “Food Supplements” released its first report highlighting the potential health risks of 117 substances, including botanicals, used in food supplements. Thirteen substances, such as Coumarin, Curcumin, and Melatonin, were identified as particularly critical. The report recommends that the European Commission have the European Food Safety Authority (EFSA) evaluate these substances, potentially leading to legislative restrictions or prohibitions. Food Business Operators are advised to handle these substances with caution.
Read the report here

La Charte Qualité des Pratiques Professionnelles dans l'industrie du Dispositif Médical

Depuis mars 2022, la Charte des Pratiques Professionnelles est en vigueur, encadrant et renforçant les pratiques commerciales liées à la promotion, l’information et la présentation des dispositifs médicaux (DM) et dispositifs médicaux de diagnostic in vitro (DMDIV).
Actuellement, la HAS élabore un référentiel de certification pour garantir le respect de la charte par les entreprises certifiées. En attendant sa publication, il est crucial que les entreprises commencent à se préparer en interne pour se conformer à ces nouvelles exigences réglementaires. Qui est concerné ? Fabricants, Mandataires, Distributeurs de DM/DMDIV inscrits à LPP. Ce qu’on vous propose ?
Un accompagnement complet par nos experts DM/DMIV, étape par étape, jusqu’à la certification !
Inscrivez-vous à la formation Charte PP

DIA Annual Meeting San Diego Recap

The DIA Annual Meeting San Diego was an amazing experience for ProductLife Group! We loved seeing so many happy faces at our exhibition stand and enjoying coffee together.
Our Innovation Theater session on AI in Regulatory Affairs by Gabrièle Breda and Barbara Lassoff was definitely a highlight with attendees asking thought-provoking questions and engaged with us throughout. We’re also thrilled and honored to have received the Author of the Year at the INSPIRE Awards on behalf of our colleague Judith ter Horst. Congratulations, Judith.
A big shoutout to everyone who made the event memorable!
Let's continue the conversation

Throwback to AFI Symposium

What an inspiring 3 days at the AFI Symposium! The ProductLife Group team (LifeBee, Pharma D&S, C&P Engineering) had a fantastic time showcasing our strengths with Global branding and deep local knowledge in the Italian Market.

Our speaking session on CPV/QPR and Digital Transformation was a standout moment, igniting meaningful conversations and highlighting our thought leadership in regulatory compliance and operational excellence.

More info on our Digital Transformation services

UK Medical Device News

The MHRA in the UK released a statement of policy intent. The goal is for the MHRA to recognize the approval of medical devices from regulators in Australia, Canada, the EU, and the USA. This proposed policy runs in parallel with the UKCA mark authorization, which is still an attractive option for those wanting to launch their medical devices in the UK. The MHRA continues to review the list of comparable regulator countries and is actively discussing with the Pharmaceuticals and Medical Devices Agency (PMDA) to explore the recognition of medical device approvals from Japan. The proposed frameworks are still in draft form, but the final version would be integral with the future core regulations.
Stay updated on future medical legislation with PLG

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June 2024 Monthly Newsletter