We are happy to announce the acquisition of SciencePharma, a life science consultancy company based in Warsaw, Poland and known for its expertise in regulatory affairs and scientific consultancy. "This acquisition is a crucial step towards realizing our #QbDream. It solidifies our presence in Eastern Europe while enhancing our team's regulatory and product development expertise." - Bart Van Acker, CEO QbD Group We are very excited for this new milestone! ✨ Read the full press release here 👉 https://hubs.li/Q02-j9W_0
About us
The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 650 high-qualified employees. Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following divisions: • Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle. • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy. • Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software. • Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities. • Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products. • Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU). • Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.
- Website
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https://qbdgroup.com
External link for QbD Group
- Industry
- Business Consulting and Services
- Company size
- 501-1,000 employees
- Headquarters
- Antwerp, Flemish Region
- Type
- Privately Held
- Specialties
- Validation, Quality management, Technology transfer, Training (GMP, GAMP5, GLP, GDP), Auditing, GAMP5, Qualification, QbD, QMS, GMP, Serialization, Data integrity, GDP, Consultancy, medical devices, MDR, MDD, biotech, and regulatory
Locations
Employees at QbD Group
Updates
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The end of the year is all about giving back—and at QbD Group, we take that to heart. 💉 💙 Our QbD Group Foundation brought our QbD'ers together in November for an incredible blood donation event. Did you know that a single blood donation can save up to three lives? A huge thank you to everyone who rolled up their sleeves to help others in need. A special thank you to Charlotte Van Gyseghem for organizing this. 🙌 #QbDGroupFoundation #BloodDonation #MakingAnImpact #GivingBack
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Did you invest heavily in developing a groundbreaking life science product or service and build a sleek website to showcase it? 💻 Yet, despite your efforts, website traffic is low, and your pages don’t rank on Google for industry-related keywords. Sounds familiar? Don’t worry—you’re not alone. Our latest blog, 'The Essential Elements of Life Science SEO Marketing', is here to help. Discover insights to boost your online visibility and stay ahead in your competitive field. https://hubs.li/Q02_VGGm0 #SEO #WebsiteTraffic #LifeSciences
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In today’s world, where safety and quality assurance are paramount, toxicological monitoring studies are no longer optional—it’s a must for staying compliant and competitive. In our latest blog, we break down 5 essential toxicological monitoring tests every company should know about, and how they can drive better, safer product development. 🧪 👉 Read more: https://hubs.li/Q02_KC120 #Toxicology #ProductSafety #RegulatoryCompliance
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The #MedicalDevice industry never stands still—innovations, evolving regulations, and shifting market dynamics are constantly shaping the future of healthcare. That’s why we’re back with another Medical Device newsletter, designed to keep you informed and equipped with the latest insights, practical strategies, and resources. Explore how to craft a compelling scientific story through your website with our new webinar on-demand, delve into crucial standards and regulations for medical device software with our white paper, and stay on top of the latest regulatory changes. Happy reading! 📰✨
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📢 Regulatory update On November 26th, 2024, the Medical Device Coordination Group released a new guidance document (MDCG 2024-14) on the implementation of the Master UDI-DI solution for contact lenses. Learn more 👉 https://hubs.li/Q02_f7QV0 #Regulatory #ContactLenses #MDCG
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And that's a wrap on our Breakfast with the CEO series! 🥐☕ This year, we introduced this new initiative to give our QbD'ers a chance to connect with our CEO, Bart Van Acker, in an informal, cozy setting. From Wilrijk to Gosselies, Breda to Oxford, and all the way to sunny Madrid and Barcelona, Bart sat down with colleagues over a delicious breakfast to share insights into our company’s vision and mission, answer burning questions, and simply connect. ✅ The result? Lots of joyful conversations, new ideas, and plenty of smiles to go around. A huge thank you to everyone who joined us—it’s safe to say this was a big success! 🙌 #BreakfastWithTheCEO #TeamQbD #Joy #Partnership
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Welcome to this new edition of our Pharma newsletter! This month, we’ve curated a blend of resources and expert perspectives to help you stay on top of the latest developments in #Pharma. 💊 From ensuring #LaboratoryCompliance and mastering the #EULinguisticReview process to understanding new regulatory guidelines, this edition is packed with tools to enhance your knowledge and impact. And don’t forget to register for our webinar taking place tomorrow December 10 at 16:00 CET on #WebsiteStorytelling, where we'll help you turn science into engagement. (You can still register here: https://lnkd.in/eQ-zgM8e) Happy reading! 📰✨
Pharma Newsletter
QbD Group on LinkedIn
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Independent news platform BioVox is proudly supported by QbD Group! At BioVox, a team of independent scientists and journalists reaches 10,000+ subscribers globally, shining a spotlight on innovations across biotech, medtech, pharma, finance, and more. It is your news platform for high-quality content on the latest life sciences breakthroughs. 🌍 Got scientific news to share? Let BioVox help! • Showcasing your expertise on key topics and trends? • Announcing a scientific breakthrough via a press release? • Sharing company news with potential investors? • Promoting an event? They can help amplify your story to the right audience! 🔗 Discover more: Visit their website and sign up for their free monthly newsletter for exclusive insights. https://hubs.li/Q02-JS2J0 #LifeSciences #Biotech #Pharma #Medtech #BioVox #QbD
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Curious why usability testing is crucial for near-patient and self-testing devices under IVDR?💡 In this last video of our series, Kirsten and Sara unpack the essentials: ✅ Why usability testing is essential for compliance and safety ✅ Key guidelines and study designs ✅ Expert tips for successful usability evaluations 💻 But that's not all! Today at 4 PM, join our webinar 'Mastering Clinical Performance Studies under IVDR', where we'll dive even deeper into this critical topic. There's still time to register—don't miss out! https://hubs.li/Q02-wt3Q0