RegSmart Life Science

Bringing a new medicinal product to market is a strategic challenge.  Balancing IP protection and regulatory exclusivity is key to securing long-term competitiveness. But how do you maximize protection while ensuring return on investment? Join us on February 20 in Umeå for a in-depth seminar where industry experts Marie Gårdmark, Ph.D. (RegSmart Life Science), Joanna Applequist, Ph.D. (AWA), and Louise Jonshammar (AWA) discuss this question and a range of strategies to optimize market exclusivity. 🕐 When - February 20, 13-14.  📍 Where - Umeå Biotech Incubator 👉 See you there! #RegSmart #LifeScience #Pharma #IPProtection #RegulatoryExclusivity #Biotech #Innovation #MarketExclusivity

A warm welcome to David Eskhult! We’re excited to introduce our newest Senior Consultant, David Eskhult, who joined RegSmart Life Science in January! David brings an exceptional combination of expertise in medical devices, regulatory compliance, and quality management. David’s impressive career spans over 20 years, with extensive experience in process validation, cleanroom environments, and implementing quality management systems. He has worked on complex projects involving high-risk implantable devices, sterilization processes, and manufacturing for Class III medical devices. Before joining RegSmart, David held senior roles at leading companies such as Nordberg Medical AB, Pharm Assist Sweden, and Rechon Life Science. His deep understanding of regulatory frameworks like ISO 13485 and MDR, combined with his practical manufacturing knowledge, makes him a valuable asset to our clients. David’s wealth of experience in supplier audits, risk management, and technical documentation ensures our clients receive the highest standard of support throughout their product lifecycle. We’re thrilled to have David as part of the RegSmart family and look forward to seeing the impact of his expertise on our projects and clients. Join us in welcoming David to the team! 📩 If you’d like to connect with David, feel free to reach out at david.eskhult@regsmart.se. #NewTeamMember #RegSmart #MedicalDevices #RegulatoryCompliance #QualityManagement

Key considerations for getting you medical device to the market. Bringing a medical device to market is no small feat. Even experienced developers and researchers can benefit from reflecting on these critical areas: 🔍 Strategic planning is key: Any adjustments in your strategic plan likely impacts your regulatory strategy. Aligning with MDR or FDA requirements early can streamline approval processes, minimize delays, and improve time-to-market outcomes. 📑 Documentation quality over quantity: Technical files are more than just a regulatory checkbox. Are they clear, relevant, and compliant? High-quality, well-organized documentation not only facilitates reviews but also demonstrates your commitment to excellence. ⚙️ Dynamic risk management: With lifecycle changes, are your risk management processes capturing new risks or evolving use cases? Staying proactive here isn’t just about compliance, it’s about future-proofing your product. 🛡️ Leveraging post-market intelligence: Beyond surveillance, how are we leveraging real-world data to refine our products and strengthen our regulatory submissions? The MDR landscape rewards proactive learning from post-market insights. 🤝 Collaborating with notified bodies: Technical files are more than just a regulatory checkbox. Are they clear, relevant, and compliant? High-quality, well-organized documentation not only facilitates reviews but also demonstrates your commitment to excellence. MDR isn’t new to this audience, but it´s evolving nature challenges us to refine, adapt, and continuously improve. As industry professionals we’re shaping the future of safe and effective medical devices. 💬 What strategies have you found most effective in staying ahead of MDR challenges? #RegSmart #MedicalDevices #MDRCompliance #Innovation

Meet the team at RegSmart – Eva Ragnarsson, PhD At RegSmart Life Science, our work revolves around supporting clients through the complexities of pharmaceutical development. This wouldn’t be possible without the dedicated experts on our team. Today, we’re proud to introduce Eva Ragnarsson, whose expertise in pharmaceutical formulations and regulatory science makes a significant impact for our clients. With over 20 years of experience in pharmaceutical sciences, Eva has a unique background that spans regulatory authorities, consultancy, and academic research. Her specialization lies in pharmaceutical formulations, including traditional drug products, pediatric formulations, and veterinary medicines. Eva spent more than 15 years at the Swedish Medical Products Agency (MPA) Läkemedelsverket as a Chemistry and Pharmaceutical Assessor, where she reviewed marketing authorizations, clinical trials, and regulatory variations. Her in-depth understanding of regulatory pathways ensures that our clients receive clear, actionable guidance at every step of their development journey. Her academic foundation is equally impressive. With a PhD in Pharmaceutical Sciences from Uppsala universitet, Eva’s research focused on microparticulate drug delivery systems and their transport mechanisms across epithelial cells. This strong scientific background allows her to bridge the gap between innovation and regulatory compliance seamlessly. Want to get in touch with Eva? Feel free to email her at: eva.ragnarsson@regsmart.se. Learn more about Eva and how her expertise can support your pharmaceutical development here: https://lnkd.in/dN_MRNmm #RegSmart #PharmaceuticalDevelopment #RegulatoryScience #DrugFormulations

This week I participated at Uppsala internation bussiness week. I got to dive into one of my favorite topics: Global Regulatory Strategy and how the new European regulations are shaking things up for MedTech and Pharma. It’s a complex field, but I truly believe conversations like these help us navigate the challenges and spot the opportunities. I shared the stage with Daniel Petrini CEO & Founder of Stardots, and Åsa Wallin Investment Manager at Almi Invest. Their insights added a lot of depth and value to the discussions during the day. Shoutout to Almi Uppsala for putting together such a great event and to everyone who joined my session. 📸 Sharing a few pics from the day. Were you at the event? Leave a 👍 in the comments and share your thoughts. #GlobalRegulatoryStrategy #MedTech #Pharma #Almi #UppsalaInternationBussinessWeek

We want to extend our sincere thanks to Andrea Hagström and Elise Nordenberg for the great time you have spent with us at RegSmart Life Science during your master’s theses. It has been both a privilege and a true joy to work alongside you as your supervisors. Your curiosity, dedication, and ambition have been nothing short of inspiring, and your engagement throughout this work has left a lasting impression on our team. Your contributions have truly enriched our work, and we are so proud to have been part of your academic work and the start of your professional journey. Wishing you every success as you take the next steps in your careers. We are confident you will continue to achieve great things! Andrea Hagström Examining the Integration of Critical Quality Attributes and Critical Process Parameters in the European Pharmacopoeia: A Focus on Quality Testing for Topical and Transdermal Administration Elise Nordenberg A Study of Recent Trends in Clinical Efficacy Evidence for Marketing Authorization of Orphan Medicinal Products by the EMA and the FDA Best of luck on the exciting path ahead! 🌟 #RegSmart #regulatoryscience #masterthesis #orphandrugs #topicaldrugs

Good advice doesn’t have to be expensive! Drug development can feel like rocket science, and questions tend to pile up even when your innovation is groundbreaking. At RegSmart, we believe that an ounce of prevention is worth a pound of cure. That’s why we, together with our partner companies, offer insights from an experienced team of experts in key areas of drug development. Our Advisory Group is here to guide you, and your first session is on us. We can add real value to your journey. Let’s get started! Email us at 👉 info@regsmart.se to take the first step. #RegSmart #LifeSciences #Pharma #DrugDevelopment #Expertise #Innovation #Support Center for Translational Research Sweden Toxicology Knowledge Team Sweden AB CTC Clinical Trial Consultants AB MetaSafe

On January 22, industry leaders and experts will gather in Uppsala for Uppsala International Business Week (UIBW 2025) – a week dedicated to inspiration, knowledge sharing, and networking. This year’s theme highlights innovation, technology, and business development, with a special focus on Life Science. We are excited to share that Marie Gårdmark, CEO & Senior Advisor at RegSmart, will be speaking on: "Global Regulatory Strategy & Medtech and Pharma in the New European Regulations" 📅 When: Wednesday, January 22 ⏰ Time: 10:00–12:00 Marie has extensive experience in regulatory affairs within Life Science. She will provide valuable insights on how companies can successfully navigate the new European regulations and identify the optimal path from innovation to market. About the event: UIBW is an essential meeting point for entrepreneurs, decision-makers, and industry experts. It’s a fantastic opportunity to attend thought-provoking presentations, participate in discussions, and network with peers driving progress forward. 🎟️ Tickets: Learn more about the program and secure your spot here: https://lnkd.in/dP8d3HKX We look forward to seeing you there. 👉 Are you planning to attend UIBW 2025? Let us know in the comments. #RegSmart #UIBW2025 #LifeSciences #MedTech #Pharma #RegulatoryStrategy #Innovation #Uppsala

At the SwedenBIO Summit, the Life Science Barometer was presented, highlighting key trends and challenges in our industry. At RegSmart Life Science, we recognize just how important regulatory competence is for life science companies tackling these complexities. The image of overlapping industry segments really resonated with us, it’s exactly what we see in many of our clients projects. By combining expertise in both pharma and medtech, our team works together to provide tailored solutions. The Summit wasn’t just about insights, it was also a fantastic chance to connect! Meeting new people and catching up with familiar faces always creates ideas and new collaborations. What were your highlights from the Summit? Share your thoughts in the comments. #RegSmart #SwedenBIO #LifeSciences #MedTech #Pharma #RegulatoryAffairs #Networking #Innovation Mats Högberg, Agneta Larhed, Marie Gårdmark

🎄 As we wrap up 2024, we can't help but feel grateful for the incredible journey we've had. It's been a year filled with new collaborations and innovative acheivements in the ever changing regulatory landscape. We truly appreciate all our partners, clients, and colleagues who have made it such a rewarding experience. From all of us at RegSmart, we wish you a wonderful holiday season. Here’s to an even brighter 2025! 🌟 #RegSmart #SeasonGreetings #ThankYou #Innovation #RegulatoryAffairs #LifeSciences #MedTech #Pharma