Arex Advisor

Happy Swedish semla day! 😀 Today, Sweden unites over one of our most beloved traditions—a national fika featuring the iconic semla! Whether you prefer the classic version, a modern twist, or simply an excuse to enjoy extra whipped cream, this day is all about indulgence, community, and sweet Swedish heritage. ☕ Important questions that arose during our semla celebration: 1. Is it correct behaviour to use a knife and fork to eat your semla? 2. Should the semla be disassembled, or eaten in one unit? 3. If you have a moustache, what is the best approach to eating your semla in style? Feel very free to share your thoughts in the comments. Few things bring us together like good coffee, good company, and a perfectly fluffy bun. Team Arex wishes you all a good semla day! 🙂 #arexadvisor #SemlaDay #Fettisdagen #FikaTime #SwedishTraditions

Wonderful to see such happy faces after Nelly Fransén shared her knowledge and expertise! 😀 Are you looking for support with Quality Assurance and Regulatory Affairs? Let’s connect! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #CMC #qualityassurance #consultancy #marketaccess #pharmacovigilance

Curiosity – a virtue of the young or a life-long mindset? 🔎 Early in your life science career, curiosity is one of the most powerful tools. Last night’s networking event was a perfect example of that. Our young professionals, Alice Olsson and Kristin Augustsson, enjoyed insightful conversations with experienced professionals and exchanging ideas with peers. Every discussion was an opportunity to learn something new. At Arex, we are firm believers in curiosity as a key to success. You never get too senior to learn new things. Do you agree? Thank you, The Swedish Association of the Pharmaceutical Industry, LIF and Karolina Antonov for creating this platform for learning together and thank you to all the speakers at the event. Are you looking for support with regulatory affairs? Let’s connect! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #CMC #qualityassurance #consultancy #marketaccess #pharmacovigilance

Welcome to the Arex Advisor newsletter! 📧 On a regular basis, our stellar team shares their knowledge of the ever-evolving regulatory landscape. We discuss the life sciences industry from a regulatory angle, offering views ranging from macro-level strategy to operational excellence. You can expect: 💡 Expert Insights: In-depth perspectives from subject matter experts with longstanding experience in navigating complex regulatory landscapes. 💡 Practical Guidance: Actionable guides and hands-on advice to help you tackle challenges in Regulatory Affairs, CMC, Quality Assurance, Market Access, and Pharmacovigilance with confidence. 💡 Inside Arex Advisor: An exclusive glimpse into our growth culture, always striving to support success for our clients. Please use this link to subscribe: https://lnkd.in/dTX5Zy_C We look forward to connecting with you!

The role of labelling in a marketing authorisation application project. Effective labelling is not just a regulatory necessity, it’s essential for patient trust and product success. Our experts have created a guide to share valuable insights on vital labelling considerations, common pitfalls, and best practices. Hopefully, it can help make your journey towards MAA/NDA/BLA as seamless as possible. Welcome to read the guide here: https://lnkd.in/gPGm4NY7 Are you looking for support in Regulatory Affairs? Let’s connect! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #labelling #CMC #qualityassurance #marketaccess #pharmacovigilance #MAA

Welcome to stand G5 at DIA Europe in Basel! 💎 Once again, we look forward to exhibiting at DIA Europe. The conference is always a highlight of the year! Our CEO Linda Thunell and COO Lovisa Rosenquist are excited to network with industry colleagues and join the discussions about all things regulatory. Great coffee and Swedish fika will be waiting for you in stand no. G5. ☕ The My DIA app is now open to all attendees. Let’s connect. Looking forward to seeing you in Basel! #arexadvisor #DIAEurope2025 #regulatoryaffairs #DIA #CMC #qualityassurance #consultancy #marketaccess #pharmacovigilance

Exploring the future of Regulatory Roles. What does the regulatory role look like today, and how will it evolve in the future? These topics were on the agenda last night, at the Topra in Sweden network meeting. Rolf Eriksson, Senior Expert Regulatory Affairs, shared his experience and insights from a consultant’s perspective. A few contexts where regulatory consultants can add significant value were highlighted: ✔️ Serving as a stable support in times of critical change, such as M&As, product purchases, peaks in workload, or organisational restructuring. ✔️ Being a sparring partner in strategic discussions ✔️ Providing knowledge and experience, not only workforce – sometimes specialists are needed. ✔️ Interim solutions during hiring processes, since recruitment of senior roles often is time-consuming. The panel discussion with representatives from various parts of the regulatory business raised some very interesting points about how the regulatory role will develop in the future. One angle was that problem solving skills and ability to understand the bigger picture are crucial qualities for regulatory affairs professionals to succeed. Thank you Topra in Sweden for a splendid arrangement and insightful discussions. Are you looking for regulatory support? Let’s connect! contact@arexadvisor.com #arexadvisor #regulatoryaffairs #topra #CMC #qualityassurance #consultancy #marketaccess #pharmacovigilance

CTIS news – updates for sponsors from the EMA The CTIS newsflash, circulated by the EMA on 11 February, sends a few messages to sponsors engaging in clinical trials. We have summarised the main points: ▪️ Get advice to improve your applications (CTAs and MAAs) - the ACT EU pilots offering advice to applicants remain open. ▪️ The period for transition from CTD to CTR ended on 30 January. The CTCG has published a guide for sponsors with ongoing trials without CTR approval. Did you miss the deadline? ▪️ Sponsors are advised to plan and submit End of Trial notification in CTIS, as well as carefully plan for management of Substantial Modifications. Do you need support with your CTIS submission? Our experts are here to help. Let’s connect! contact@arexadvisor.com #regulatoryaffairs #clinicaltrials #CTIS #EMA #CTR #CTA #qualityassurance #CMC

Is your regulatory affairs team up to speed with the new EU-HTAR? The implementation of the new EU Health Technology Assessment Regulation has begun. With this, the importance of cross-functional collaboration in regulatory affairs and market access is intensified. Our expert Susanne Schuurman frequently educates regulatory affairs professionals about the opportunities and challenges the new regulation holds for health technology developers. Susanne has summarised the most asked questions: ▪️ Are health technology developers ready for the new processes, especially smaller companies? ▪️ What are the timelines for JCA during an accelerated EMA process, and what are the implications for HTDs considering this path? ▪️ What can local regulatory affiliates expect in terms of launch dates in individual countries?   Are questions like these up in the air in your organisation? Our experts are here to help. Let’s connect! contact@arexadvisor.com For a general overview of the EU-HTAR, Joint Clinical Assessments and Joint Scientific Consultations – visit our guides: https://lnkd.in/dWSZnWF3 https://lnkd.in/dSjzKq_3 https://lnkd.in/d-GyWMkh #arexadvisor #HTA #EUHTAR #JCA #JSC #MedTech #pharma #healthtech #regulatoryaffairs #marketaccess #CMC #qualityassurance

Inspiring innovation and networking at BII Demo Day VL#6. 🌠 Last week, Callum James Kitson-Parker, our Expert Consultant MedTech, had the opportunity to attend the BII Demo Day for Venture Lab Cohort 6, where 10 startup companies who have recently completed the BII Venture Lab program pitched their exciting and inspiring products. “It was an absolute pleasure to watch the pitches and meet some of the companies who are leading the way in healthtech, therapeutic and quantum innovation.” Thank you BioInnovation Institute for the excellent arrangement. And thank you Alice Mattsson and Odd Stang-Lund Sanne for the great photo collaboration. 📷 Are you looking for support in Regulatory Affairs and Quality Assurance? Let’s connect! contact@arexadvisor.com #arexadvisor #MedTech #healthtech #innovation #regulatoryaffairs #CMC #qualityassurance #marketaccess #pharmacovigilance