RegSmart Life Science

FDA has recently released an updated version of the Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs. One significant change is that it now includes Nitrosamine Drug Substance Related Impurities (NDSRIs), and how they can be controlled. For instance, it may be necessary to reformulate a drug product where the levels of nitrosamines as related substances increase during storage. The updated guidelines also describe how a bioequivalence assessment for the reformulated product can be performed. 👉 Do you want to know more? So do we! Therefore, we plan to listen in to the online workshop that FDA and CRCG will host on November 6-7. Don't miss out—check out the details and register here:  https://lnkd.in/d3gh6gkv #RegSmart #Regulatoryaffairs #Pharma #Compliance #FDA #CRCG #Nnitrosamines #LifeScience

Last week, we had the joy of celebrating with STUNS Foundation for Collaboration between the Universities in Uppsala, Business, and Society, marking their 40th anniversary! 🎉 For 40 years, STUNS has brought people together in Uppsala to foster innovation, collaboration, and sustainable growth. Agneta Larhed and Marie Gårdmark from RegSmart Life Science participated in the celebration and we’re proud to be part of an industry that thrives on teamwork, creating future-ready solutions together. A huge thank you to STUNS, Governor Stefan Attefall, Andreas Larsson, and everyone else who made this event so special. And of course, a big thanks to our partners, colleagues, and friends in the industry who work tirelessly every day to push progress forward. The afternoon and evening was filled with inspiring conversations, shared insights, and a common vision to keep pushing the boundaries of what's possible in regulatory affairs. We’re excited for what’s next - let’s keep moving forward together! 🚀 #RegSmart #Collaboration #Innovation #DrugDevelopment #LifeSciences #RegulatoryAffairs #Future

Last Wednesday, our CEO Marie Gårdmark participated in an inspiring meeting with the Scientific Council at Apotekarsocieteten, where leading experts in pharmaceutical research discussed current issues and future opportunities. 💊 These kinds of meetings are a fantastic chance to exchange knowledge and strengthen our understanding of the scientific challenges we face. The Scientific Council is an invaluable platform that brings together researchers, practitioners, and the industry, and we are proud to be part of these discussions. A big thank you to everyone who participated and contributed to such an engaging and productive discussion. Want to learn more about how we can support your drug development project? 👉 Get in touch, and let's talk: https://lnkd.in/dJ-Ss7fc #Apotekarsocieteten #ScientificCouncil #PharmaceuticalResearch #RegSmart #LifeSciences

Is your pharmacovigilance system in need of an audit? Regular pharmacovigilance audits are crucial to ensuring compliance with pharmacovigilance requirements and the effective operation of your safety systems. At RegSmart, we offer independent audits that thoroughly assess your safety monitoring system, including quality management in line with pharmacovigilance legislation. From internal audits to reviewing your PV service providers and partners, we provide personalized and expert support whenever you need it. With years of experience conducting audits and inspections across Europe, we make sure you’re prepared for an authority inspection. Let us help you maintain compliance with regulatory standards and confidence in your pharmacovigilance systems. Our services include: - Internal PV audits - Audits of PV service providers - Supplier/partner audits Feel free to reach out to learn more about how we can support your audit needs. 👉 https://lnkd.in/d9GuCgCv #Pharmacovigilance #Audits #RegulatoryCompliance #DrugSafety #RegSmart #GVPCompliance

We are very proud that our regulatory expert, Marie Gårdmark, who brings over 25 years of experience from regulatory authorities and pharma industry, recently gave a lecture at the 3-day Drug Development course at Läkemedelsakademin.  Marie delivered a lecture titled "Fit for purpose regulatory strategy", sharing her deep knowledge on how to tailor regulatory strategies to optimize the approval process. It was a fantastic opportunity to exchange insights and discuss current challenges with some of the leading figures in the industry. At RegSmart, we’re always eager to share our knowledge and help companies navigate the complex regulatory landscape. We appreciate the opportunity to connect with industry professionals and contribute to the discussions. A sincere thank you to the organizers and participants for creating such a valuable learning experience! ⭐ #RegSmart #MarieGårdmark #FitForPurpose #DrugDevelopment #RegulatoryAffairs #LifeSciences #Lecture #PharmaceuticalDevelopment

Together towards success: Client experiences ⭐ We love hearing from our clients! Recently, we had the pleasure of working with NanoEcho on their innovative solution for rectal cancer diagnosis. Their feedback highlights our commitment to guiding companies through complex regulatory landscapes, ensuring that their groundbreaking products meet all necessary compliance standards. “RegSmart has been very helpful for us in understanding the regulatory requirements for our innovative solution, especially for setting up the clinical studies for the combination product. Since classification and claims impact the regulatory route we need to follow, they also affect the cost and time to market. Therefore, RegSmart’s experience with combination products and their scientific understanding has been valuable in helping us find the optimal path forward.” - Dr. Ulrika Axelsson, Clinical Director at NanoEcho We are proud to be a trusted partner in their journey. Check out their testimonial to see how we can help you navigate your regulatory challenges! 👉 RegSmart - Testimonial: https://lnkd.in/dEcqtCi6 #CustomerSuccess #Testimonials #RegulatoryAffairs #Pharma #MedTech

RegSmart at the 2024 Stockholm-Uppsala Life Science Conference! 👩🔬 RegSmart was proud to participate in the 2024 Stockholm-Uppsala Life Science Conference, hosted at the renowned Karolinska Institutet on October 10. This event highlighted the vibrant and innovative life science cluster emerging from the dynamic collaboration between academia, industry, and healthcare. Organized by Region Stockholm and Region Uppsala, the conference showcased cutting-edge developments shaping the future of life sciences. Achieving successful innovation in this sector requires not only creativity, but also the right regulatory expertise with scientific knowledge and commercial insight to guide ideas from conception to market launch. The Uppsala-Stockholm Life Science Cluster is one of Europe's leading life science hubs, anchored in Sweden’s Stockholm-Uppsala region. With a thriving ecosystem of universities, research institutions, hospitals, and forward-thinking companies, it is at the forefront of advancing healthcare, biotechnology, pharmaceuticals, and medical technology. We’re excited to be part of this vibrant ecosystem and look forward to collaborating with industry leaders to drive innovation forward. If you want to learn more about how RegSmart can support your journey in navigating the regulatory landscape, feel free to reach out. Contact us ➡️ https://lnkd.in/dJ-Ss7fc 📷 Pictured: Mats Högberg with Björn Arvidsson, Director at STUNS and one of the event organizers. #RegSmart #LifeScience #Innovation #RegulatoryAffairs #Healthcare #KarolinskaInstitutet

What We Do at RegSmart! At RegSmart, we understand the challenges you face when navigating complex regulatory pathways. We combine deep regulatory knowledge, scientific expertise with commercial understanding to help bring your product to market successfully. 👩🔬 Regulatory Expertise: We stay on top of the latest regulations to ensure your strategy is always one step ahead. ⚗️ Science-Driven: Our tailored studies provide the right data to support your regulatory submissions. 🔬 Purpose-Built Solutions: We bridge the gap between regulations and real-world market needs, ensuring both compliance and commercial success. Why RegSmart? We don’t just guide you through regulatory hurdles; we partner with you to turn challenges into opportunities. Let’s work together to ensure your product is compliant, market-ready, and primed for success. ➡️ Contact us today and let’s make your regulatory journey a smooth one. https://lnkd.in/dJ-Ss7fc #PharmaRegulations #LifeSciences #RegulatoryCompliance #Pharmacovigilane #MedTech #ClinicalTrials #FDACompliance #DrugDevelopment #MedicalDevis #RegulatoryStrategy

Welcome Aboard, Sonya Stenfelt! 🌟 We’re thrilled to introduce our newest Senior Consultant, Sonya Stenfelt, who joined RegSmart in September! With a PhD in polymer chemistry and extensive expertise in biomaterials and stem cells, Sonya brings a wealth of knowledge in regenerative medicine. Her impressive background includes navigating complex regulatory landscapes under ISO 13485 and QSR, overseeing manufacturing changes, and scaling production for global markets. Sonya's dedication to innovation will undoubtedly enhance our team and our clients' success. Join us in welcoming Sonya to the RegSmart family! If you’d like to connect with her, feel free to reach out at ➡ [email protected] #newteammember #regsmart #regulatoryconsulting #biomaterials #regenerativemedicine

WE ARE NOW A REGISTERED SME IN THE EU! This means we can act on behalf of any client who do not have a legal entity based in the EU/EEA, to access SME benefits and fee incentives offered by EMA. A proviso is that the non-EEA organisation also meet the criteria for an SME. The incentives provided by EMA to SMEs within the human and veterinary sectors include: 📍 Significant Fee incentives for e.g. Scientific advice, protocol assistance, Inspections,post-authoriasation procedures etc. 📍 Assistance from the EMA’s SME office including SME briefing meetings. 📍 Certification of quality/ non-clinical data for advanced therapy medicinal products (ATMPs) intended for human use; 📍 Translations of the product information documents 📍 Waiver of the MedDRA licensing fee when registering with EudraVigilance, (available for micro- or small enterprises). 📍 Information updates: EMA SME newsletters and invitations to free EMA SME training events. 📍 Some of the EU Authorities also provide national support to companies with SME status. Please contact us for more information on our support for SMEs.