ProductLife Group

ProductLife Group

Fabrication de produits pharmaceutiques

Courbevoie, Île-de-France 76 024 abonnés

À propos

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 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, 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.

Site web
http://www.productlifegroup.com/
Secteur
Fabrication de produits pharmaceutiques
Taille de l’entreprise
501-1 000 employés
Siège social
Courbevoie, Île-de-France
Type
Société civile/Société commerciale/Autres types de sociétés
Domaines
Data Management, Full Dossier preparation, production, submission and maintenance, Product Safety management, Pharmacovigilance, Artificial Intelligence, Regulatory Affairs, Market Access, Clinical Safety, Publishing, Labelling, e-CTD, CMC, Quality Assurance, Cosmetics, Medical Devices, CCDS, Scientific Advice, RIM: Regulatory Information Management, Full Dossier, IDMP, Guidance Interpretation, Strategic Consultancy, Gap analysis, Regulatory Intelligence, Due Diligence, Bibiliographic research, QPPV, Medical Writing, ERA, Medical Information, Promotional Material, RMP et Medical Device

Lieux

Employés chez ProductLife Group

Nouvelles

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    76 024  abonnés

    Rni, ProductLife Group Self-Care center of expertise, keeps you updated on the latest Nutrition regulations. The FDA has published new resources to aid compliance with the Food Traceability Rule. These include: - A downloadable, electronic sortable spreadsheet template. - Revisions to the Food Traceability List, including a new FAQ. - A chart of exemptions for produce farms related to the Produce Safety Rule and the Food Traceability Rule. - A supply chain example for sprouts. - Translated material about the Traceability Lot Code and Traceability Plan. Follow us for more details about the latest updates in the industry. #nutrition #fda #foodtraceabilityrule #food #healthcare #selfcare #pharma #regulatory

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    2 094  abonnés

    #RNINews - #ProductLife | ℹ FSMA Final Rule on Requirements for Additional Traceability records for Certain foods The FDA has published new resources to help industry comply with the #Food Traceability Rule. These include: ✔ A downloadable, electronic sortable spreadsheet template; ✔ Minor revisions to the Food Traceability List clarifying the status of previously frozen foods on the list, as well as a new FAQ summarizing the changes; ✔ A chart summarizing exemptions relevant to produce farms for both the Produce Safety Rule and the Food Traceability Rule; ✔ A supply chain example for sprouts; and ✔ New translated material about the Traceability Lot Code and the Traceability Plan. For more regulatory, scientific & industry updates in nutrition, health, borderline & medicinal products visit our website or follow us on social media and follow our hashtag #RNINews

    FSMA Final Rule on Requirements for Additional Traceability Records

    FSMA Final Rule on Requirements for Additional Traceability Records

    fda.gov

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    76 024  abonnés

    🥂🎉 Let’s celebrate with our LifeBee’s colleagues their 20 years of excellence in the digital transformation of Life Sciences in Europe. More than that, the moto of that 20th anniversary, #ATN (𝘈𝘭𝘭 𝘛𝘰𝘨𝘦𝘵𝘩𝘦𝘳 𝘕𝘰𝘸), might also be the one of ProductLife Group. Indeed, on the 11th of July, ProductLife Group's CEO Xavier Duburcq took that opportunity to talk about the integration of LifeBee into PLG, highlighting the synergies and growth opportunities of our companies in the coming months. This vision was detailed by Maria Ana Castello Branco, Head of Integration & Transformation for the Group, stating the integration's positive impact in Italy, with a projected 20% revenue growth in 2024. Finally, Candice Bosson, PLG’s Chief People Officer introduced groundbreaking HR initiatives, including the Social Ambassadors and Buddy Program, aimed at fostering a supportive community. She reminded all experts from LifeBee that PLG’s Academy continues to excel, offering over 100 courses and numerous learning paths to all consultants of the Group. Read more about our success stories by following us. #OnePLG #LifeBee #lifesciences #pharma #companyanniversary #growth #success #digitalization #digitaltransformation

    Voir la page d’organisation pour LifeBee, visuel

    4 928  abonnés

    𝟮𝟬𝟮𝟰 𝗟𝗶𝗳𝗲𝗕𝗲𝗲 𝗦𝘂𝗺𝗺𝗲𝗿 𝗔𝗧𝗡: 𝟮𝟬𝘁𝗵 𝘆𝗲𝗮𝗿𝘀 𝗮𝗻𝗻𝗶𝘃𝗲𝗿𝘀𝗮𝗿𝘆 𝗲𝗱𝗶𝘁𝗶𝗼𝗻!   We have these special moments in LifeBee, called #ATN (𝘈𝘭𝘭 𝘛𝘰𝘨𝘦𝘵𝘩𝘦𝘳 𝘕𝘰𝘸), great opportunities for all of us to meet and to go through the key moments of our work, and our last ATN was also the occasion to celebrate our 𝟮𝟬𝙩𝙝 𝙖𝙣𝙣𝙞𝙫𝙚𝙧𝙨𝙖𝙧𝙮! We took a journey through the past two decades of our company's history, celebrating milestones and achievements that have brought us to where we are today, now as part of ProductLife Group. We were honored to share this celebration with our #PLG colleagues in the beautiful location of Fondazione Luigi Rovati, accompanied by the enchanting violin music of Eleonora Montagnana. These past 20 years stand as a testament to our unwavering #commitment, #dedication, and #passion. Throughout this journey, we have always been inspired by Bertrand Russell's mantra: "𝘈𝘯𝘺𝘵𝘩𝘪𝘯𝘨 𝘺𝘰𝘶'𝘳𝘦 𝘨𝘰𝘰𝘥 𝘢𝘵 𝘤𝘰𝘯𝘵𝘳𝘪𝘣𝘶𝘵𝘦𝘴 𝘵𝘰 𝘩𝘢𝘱𝘱𝘪𝘯𝘦𝘴𝘴". None of our achievements would have been possible without the hard work and dedication of our incredible Team, whose efforts have shaped LifeBee into what it is today. As we look ahead to the future, let's remember that our true strength lies in our People - 𝘵𝘩𝘢𝘵 𝘮𝘰𝘳𝘦 𝘵𝘩𝘢𝘯 𝘢𝘯𝘺𝘵𝘩𝘪𝘯𝘨 𝘮𝘢𝘬𝘦 𝘰𝘶𝘳 𝘤𝘰𝘮𝘱𝘢𝘯𝘺 𝘴𝘰 𝘴𝘱𝘦𝘤𝘪𝘢𝘭 𝘢𝘯𝘥 𝘶𝘯𝘪𝘲𝘶𝘦 - and their relentless pursuit of excellence. 𝙃𝙚𝙧𝙚'𝙨 𝙩𝙤 𝙢𝙖𝙣𝙮 𝙢𝙤𝙧𝙚 𝙮𝙚𝙖𝙧𝙨 𝙤𝙛 𝙜𝙧𝙤𝙬𝙩𝙝 𝙖𝙣𝙙 𝙨𝙪𝙘𝙘𝙚𝙨𝙨 𝙩𝙤𝙜𝙚𝙩𝙝𝙚𝙧! 🥂 #LifeBee #DigitalizingLifeSciences #20Years #WeAreLifeBee

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      +5
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    76 024  abonnés

    ProductLife Group (PLG) is thrilled to announce the participation of Teresa Minero, Head of PLG’s Digital Business Unit, in the ISPE’s “Pharma 4.0 Baseline Guide” webinar. Read more in the below blog and contact us for details here: https://lnkd.in/eF9aT9dy #ISPE #pharma #baselineguide #digitalization #digitaltransformation #lifesciences

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    4 928  abonnés

    𝗜𝗦𝗣𝗘 𝗣𝗵𝗮𝗿𝗺𝗮 𝟰.𝟬™ 𝗕𝗮𝘀𝗲𝗹𝗶𝗻𝗲 𝗚𝘂𝗶𝗱𝗲: 𝗗𝗼𝗻’𝘁 𝗺𝗶𝘀𝘀 𝘁𝗵𝗲 𝗙𝗥𝗘𝗘 𝘄𝗲𝗯𝗶𝗻𝗮𝗿! 📌 𝘛𝘰𝘮𝘰𝘳𝘳𝘰𝘸, 𝘑𝘶𝘭𝘺 18𝘵𝘩, 2024 𝘢𝘵 5 𝘗𝘔 𝘊𝘌𝘛! We're thrilled to announce that our CEO, Teresa Minero, will be a featured speaker at the upcoming ISPE webinar discussing the recent 𝙄𝙎𝙋𝙀 𝘽𝙖𝙨𝙚𝙡𝙞𝙣𝙚® 𝙂𝙪𝙞𝙙𝙚 𝙤𝙣 𝙋𝙝𝙖𝙧𝙢𝙖 𝟰.𝟬™. This guide is a vital resource for companies aiming to achieve their innovation and competitiveness goals, while continuously improving product quality and meeting regulatory requirements. LifeBee, a ProductLife Group company, reaffirms with this initiative its position as global thought leader in #Consulting and #DigitalTransformation for #LifeSciences: Teresa Minero as Lead Author for Chapters “𝘌𝘯𝘢𝘣𝘭𝘪𝘯𝘨 𝘛𝘦𝘤𝘩𝘯𝘰𝘭𝘰𝘨𝘪𝘦𝘴” (19 have been analyzed adding their Definition, Usage, Benefits, Constraints) and “𝘊𝑎𝘴𝑒 𝑆𝘵𝑢𝘥𝑖𝘦𝑠” (a total of 35 very structured with problem statement and solution and project details), together with the valued support of Raffaella Vaiani, have made significant contribution to the whole Baseline Guide. Join Teresa Minero, along with other esteemed authors like Michelangelo Canzoneri, Yvonne Duckworth, PE, Paige Kane, PhD, CPIP, Christian Wölbeling, Vinzenz Zauner and Thomas Zimmer, for an in-depth overview on Pharma 4.0™ Guideline, followed by an open Q&A session. 📝 Register for this complimentary webinar: https://lnkd.in/dHRg3GTn   📅 Thursday, 18 July 2024Time: 11:00-12:30 EDT / 17:00-18:30 CET #ISPE #Pharma #BaselineGuide #Pharma40 #Digitalization #ConnectingPharmaceuticalsKnowledge

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    76 024  abonnés

    𝗔𝗰𝗵𝗶𝗲𝘃𝗲 𝗗𝗿𝘂𝗴 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 & 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗦𝘂𝗰𝗰𝗲𝘀𝘀 𝘄𝗶𝘁𝗵 𝗣𝗟𝗚’𝘀 𝗘𝘅𝗽𝗲𝗿𝘁 𝗧𝗲𝗮𝗺 📣 Dear Biotech and Biopharma community, We are excited to introduce our expanded capabilities in Biopharma Product Development. By leveraging the combined expertise of our affiliates DSI - DS InPharmatics, a PLG company, Zwiers Regulatory Consultancy BV, Cilatus BioPharma Consulting AG, Pharma IT, Commercial Eyes Pty Ltd and Pharma D&S - we provide access to a global team of 300+ senior consultants dedicated to supporting your drug development journey from pre-IND stages through to product launch. 👉 𝗪𝗵𝗮𝘁 𝗪𝗲 𝗢𝗳𝗳𝗲𝗿: Whether you need ad-hoc advice, full development strategies, or hands-on operational support, we can help. At ProductLife Group, we are committed to driving or supporting your development plans, fostering transparent communication, and ensuring direct access to local senior subject matter experts (SMEs) with experience in your specific drug modality and therapeutic indication. 𝗪𝗲 𝗦𝗲𝗿𝘃𝗲 𝘁𝗵𝗲 𝗘𝗻𝘁𝗶𝗿𝗲 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 & 𝗕𝗶𝗼𝗽𝗵𝗮𝗿𝗺𝗮 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝘁𝘆: PLG successfully collaborates with incubators, VCs, Biotechs, Pharmas, and CDMOs across the EU, USA, and APAC to help mitigate risks and accelerate drug development strategy from the clinic to the market. 👉 Our specialized expertise and capabilities span the entire product development lifecycle, including: - Strategic planning for non-clinical, clinical, and regulatory roadmaps - In-depth Pharmaceutical development and CMC consulting, providing both strategic and technical insights - CRO/CDMO selection, oversight and management - Complete regulatory support for IND, MAA, NDA, and BLA submissions, from document preparation to regulatory agency engagement and eCTD administration - Gap assessments of the current state of development and due diligence support - QA audit services, including EU Qualified Person (QP) release services - Quality System design, setup, and remediation, including SOP drafting and digital solutions - Early Market Access advisory We view ourselves as an extension of your team. We share your passion for developing innovative therapies and bringing them to patients. We are driven by our commitment to making your drug development journey successful! 📩 Just reach out to us here: https://lnkd.in/eF9aT9dy We’d love to learn more about your needs and discuss how we can assist you! #biotech #biopharma #drugdevelopment #regulatorysuccess #pharma #lifescience #healthcare #CMC #qualitysystem #marketaccess #gapassessment #ectd #CRO #SME

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    📢 ProductLife Group is happy to share with you that it has been granted ISO 9001:2015 certificate. ✅ This label demonstrates the commitment of the organization to implement an effective quality management system and permanently improve it. This was possible because of our employees' and managers' day-to-day engagement with quality, client satisfaction orientation, and improvement mindset. We’d like to warmly thank them all. Read more about our certification here: https://lnkd.in/ebhDRgdz #ISO90012015 #bureauveritas #qualitymanagementsystem #quality

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    [Free Webinar 💻] PRIME scheme – A tailored development 📅 Date: July 30th, 3 PM CET 🔗 Register now: https://lnkd.in/dK3eACnu In 2016, the European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme to expedite the development and regulatory approval of medicines addressing major public health needs. The PRIME scheme aims to ensure robust data generation for regulatory compliance and to identify emerging issues early in development. It focuses on medicinal products targeting unmet medical needs to help them reach patients sooner and potentially enhance their quality of life. Join our expert Alessia Cipriani to gain valuable insights on PRIME Scheme. Learn how Zwiers Regulatory Consultancy BV, part of ProductLife Group can support you. #regulatoryaffairs #prioritymedicines #ema #prime #primescheme #pharma #healthcare #lifescience #datageneration #regulatorycompliance #medicinalproducts #webinar

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    📣 EMA updated Zingiber officinale root monograph (draft version 1 - 14th of June 2024) EMA updated the ginger root monograph on June 14, 2024, expanding indications and doses beyond motion sickness and digestive health. For pregnant and lactating women, moderate data shows no toxicity, but use is not recommended due to insufficient data. 👉 Check out all the latest news of Nutrition & Food Supplements here: https://lnkd.in/eZrKbdTE ProductLife Group offers regulatory and scientific expertise for product development in nutrition, food supplements, medical nutrition, and cosmetics. Services include ensuring regulatory conformity, selecting ingredients, and managing post-marketing strategies. #rninews #ginger #ema #foodsupplements #nutrition #lifesciences

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    2 094  abonnés

    #RNINews - #ProductLife Group I EU I FR I What’s new in Nutrition & Food Supplements ? Let’s summarize some hot topics from recent authorities opinions and new peer-reviewed publications for you to be up-to-date! 6rh News : EMA updates Zingiber officinale (#ginger) root monograph (draft version 1- 14th of June 2024) EMA published a new draft version 1 – on the 14th of June for ginger root: There is an extension on the indications and daily doses in addition to motion sickness and digestive health. For pregnant and lactating women, a review of the existing literature has been performed and the conclusions are the following ones: “A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicates no malformative or feto/neonatal toxicity of ginger root. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure it is preferable to avoid the use during pregnancy. Safety during lactation has not been established. In the absence of sufficient data, the use during lactation is not recommended. “ You need a regulatory and scientific expert opinion to adjust you New Product Development Strategy and/or existing product update strategy for Self-care (Nutrition, Food Supplement, Medical Nutrition, Cosmetics) ? We may help: ✔ In adjusting or identifying the best product status depending on your claim/health benefits aimed in the appropriate target population ✔ In ensuring the regulatory conformity of the formula/label/ingredient and export strategy with our team of regulatory experts at international level ✔ In selecting a differentiating blend of actives with complementary mechanism of action ✔ In analyzing safety and efficacy data with our team of certified toxicologists and clinicians (PhD, GCP certified with experience in R&D, clinical operations) and optimize ingredient sourcing ✔ In writing the required regulatory and technical dossiers (quality, safety, claim justification, FSMP dossier, Annex II & III, PIF) ✔ In helping in the process of market authorization/notification ✔ In building and managing your post-marketing vigilance strategy ✔ In building new preclinical and clinical data for efficacy and safety of your ingredients and products More information : Véronique TRAYNARD Find the latest news on Nutrition and Food supplements on our website: https://lnkd.in/eZrKbdTE

    What's new in Nutrition & Food Supplements ? - RNI Consulting

    What's new in Nutrition & Food Supplements ? - RNI Consulting

    https://www.rni-consulting.com/en/

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    76 024  abonnés

    Our Mariangela Prada gave a lecture on 'General Principles of Market Access', during the Università degli Studi di Verona Master 3F e Real World Evidence (Pharmacovigilance, Pharmacoepidemiology, Pharmacoeconomics and Real World Evidence), providing an in-depth and practical insight into the dynamics of market access for healthcare. A precious opportunity to share her expertise and passion with the next generation of healthcare professionals. Take the next step in optimizing your market access strategy. Learn more about how PLG can help you navigate the complexities of the healthcare market here: https://lnkd.in/d2bYUxnS Intexo Società Benefit (A ProductLife Group Company) #marketaccess #hta #pharmaeconomics #rwe #pharmacovigilance #pharmacoepidemiology #pharma #lifescience #healthcare #italianmarket

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    76 024  abonnés

    🏛 What exactly is regulatory science, and why is it essential? As we explore the forefront of innovation, we invite you to discover with us in Part 5: Exploring Regulatory Science of our A Story of Innovation video series, presented by Gabrièle Breda, our Research and Innovation Director. Discover how regulatory science informs and evaluates regulatory decision-making, and learn about our contributions to advancing medical technology and improving patient outcomes with real-world examples. Don't miss this opportunity to gain insights from our R&I experts and our collaborative efforts with the healthcare innovation ecosystem, and join us in driving positive change. ▶ Watch here the full Story of Innovation: https://lnkd.in/dVfysaDs For more in-depth exploration, articles, studies, and updates, visit our Healthcare and Medical Innovation page: https://lnkd.in/d5nJrsms Join the conversation and be part of A Story of Innovation journey! #Innovation #Healthcare #LifeSciences #PLG #Inspiration #MedicalInnovation #Research #DigitalTransformation #InnovationChronicles #AStoryofInnovationPLG

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    76 024  abonnés

    Strengthening our Remote Team Spirit with Integrity ⚽ At ProductLife Group, we reinforce our commitment to a supportive and dynamic work environment and believe team building is essential for fostering strong connections and a collaborative spirit. To bring our remote teams closer together, we recently held an exciting Euros Internal Competition in the UK. We want to express our gratitude to everyone who participated. Your enthusiasm made it a resounding success! 💪 We're excited to roll out more innovative and interactive initiatives to keep our team connected and motivated. Stay tuned for more! #teambuilding #companyculture #employeeengagement #OnePLG

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    1 488  abonnés

    How does team building look to you? 🤔 For us, it's about creating connections, fostering friendships, and having fun while doing it! 🎉 As a remote-based team, we cherish every opportunity to come together, even if it's virtually. To bridge the gap and get closer to our teams and colleagues across ProductLife Group, we launched the Euros Internal Competition! 🏆 Divided into teams, we predicted scores, celebrated victories, and shared in the excitement of every match. As we approach the end of this initiative, we want to say a massive thank you to everyone who participated and made it such a success. Your enthusiasm, healthy competitiveness and team spirit have been truly inspiring! 🌟 We’re committed to bringing more exciting initiatives to keep our team engaged and connected. Stay tuned for what's next! 🚀 #TeamBuilding #CompanyCulture #RemoteWork #EurosCompetition2024 #PLG #Integrity

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