EXTEDO

What EXTEDORIANS say about us! At EXTEDO, the voices of our team members tell our story best. As Puneet Kaushik shares: "We have a very international environment, and people are open and energetic to achieve the best outcome of work we are doing." This quote reflects the vibrant, inclusive, and collaborative spirit that defines our workplace. It's the diverse perspectives and the passion of our EXTEDORIANS that drive us to innovate and succeed together! Do you want to become an EXTEDORIAN too? Explore our careers page https://lnkd.in/d7pDKfsa and join us now! #EXTEDO #EXTEDORIANS #Careers

Join our free webinar: Unlock SAHPRA 3.1 Insights: Master Regulatory Compliance and Excellence! Are you looking to stay ahead with the latest SAHPRA 3.1 developments? In this comprehensive webinar, you will gain valuable insights into the key updates in SAHPRA 3.1 eCTD specifications and learn how to ensure fully compliant regulatory submissions. Date: 05 September 2024 Time: 03:00 - 04:00 PM CEST | 09:00 - 10:00 AM EST Registration: https://lnkd.in/dcRz9Dcj Our expert speakers Maren Müller, Product Manager, and Priya Krishnan - MBA Engineering in Life Science Management, Business Consultant, will guide you through the essential structure and requirements for compliant submissions. Plus, don’t miss the live demonstration of our tool that will help you achieve successful eCTD implementation. Whether you can join us live or not, make sure to register to receive the recording! For more upcoming EXTEDO events, check out our website: https://lnkd.in/dVkmEs6D #EXTEDO #SAHPRA #RegulatoryCompliance

Ready to stay ahead in regulatory data management? EXTEDO invites all regulatory affairs professionals to join the FORUM Institut’s online event "These XEVMPD Data Must Now Be Updated for PMS" on 02 October 2024. Gain essential insights into "The Transition from XEVMPD to the PMS Database - Where Do We Stand?", presented by Dr. Anna Thaidigsmann, Principal Business Consultant at EXTEDO together with Karl-Heinz Loebel. As the February 2025 deadline approaches, this webinar is crucial for ensuring compliance. You’ll receive a comprehensive overview of current requirements, practical guidance on updating XEVMPD data, and a forward-looking perspective on PLM-eAF, PMS-UI, and PMS-API. Please note: The webinar will be held in German. Date: 02 October 2024 Time: 09:00 - 04:30 pm CET Registration: https://lnkd.in/dqgC2p3i What else can you expect? - In-depth insights into the current status of IDMP & SPOR projects. - Practical advice on updating and supplementing existing XEVMPD data. - Guidance on future developments like PLM-eAF, PMS-UI, and PMS-API. - Expert presentations on the European Shortages Monitoring Platform. We look forward to seeing you online! For more EXTEDO events, visit: https://lnkd.in/dc7ui4nF #EXTEDO #FORUMInstitut #RegulatoryAffairs #XEVMPD #PMSDatabase

As a leading Regulatory Information Management (RIM) System vendor with our comprehensive platform EXTEDOpulse, we are constantly dealing with the multiple possibilities and benefits it offers to our customers. A RIM supports organizations on various levels – some regard it as their guarantee for peace of mind, as the driving force behind seamless document management and effortlessly compliant submissions, as their steadfast ally who does the regulatory legwork or as simply a competitive advantage. But what is a RIM to people who work with it every day? Schei Dattner, our SVP Sales and Product Management, continues the series. Listening closely to customers for 25+ years, he understands exactly what their requirements are and shows them how they can be realized with our software. This is what he told us: “I consider RIM to be a full end-to-end solution platform which is based on a data management approach making the single source data available to the different business solutions which are part of the RIM. The implementation of a RIM is the chance for any company to automate and streamline its processes especially in the effort/risk associated processes such as Submission Publishing.” Thank you for your time, Schei! If you would like to talk to Schei about your company’s regulatory processes and how EXTEDOpulse can optimize them, please contact us any time! #EXTEDO #EXTEDOpulse #RIM

Join Us in Long Beach - EXTEDO at RAPS Convergence 2024! EXTEDO is excited to participate in the upcoming RAPS Convergence 2024 in the beautiful city of Long Beach, California. From 17-19 September, regulatory excellence will take center stage in the vibrant atmosphere of Long Beach. Visit Matthew Botelho, Shari Popovich and Alexander Levesque at Booth #611! As a trusted partner bridging the gap between the life sciences industry and national health authorities, we deliver Effortless Compliance in the pharmaceutical and medical device industry. Our comprehensive end-to-end life sciences solution, EXTEDOpulse, empowers organizations to transform their regulatory vision into reality. With over 35 authorities and countless clients worldwide relying on our solutions and services, we invite you to explore how your organization can elevate its regulatory excellence. Stop by our booth #611—we're eager to collaborate and help you tackle your regulatory challenges. And while you're with us, don’t miss your chance to participate in our raffle to win a Stanley Cup and build your own regulatory champion. Let's make Long Beach unforgettable! For more information, go to: https://lnkd.in/dsX2Acsd #EXTEDO #RAPSConvergence #RegulatoryExcellence #LongBeach

Stress at work is a hot topic that’s constantly being discussed. Everybody knows those hectic days when we’re just trying to keep up with our to-do lists. We should take precautions for such times and already have strategies at hand to help us keep our stress levels at a tolerable level. That’s why our recent Health Boost Day was all about "Stress Management." Open to all employees, the day featured a presentation to explain the origins of stress and its potential consequences. Along with some practical exercises, we gained valuable tips on how to counteract stress before it gets overwhelming. A standout technique we learned - and one we are sure many of us will be using - is the "relaxing break." We had the chance to enjoy one of these right after, a meditation session designed to restore balance and calm in the midst of stressful times. A big thank you to our HR department for organizing this and, of course, to our two guests, Sara Barisic and Marina Firnhaber, for their insightful contributions, helping us face new challenges with a little more peace of mind and a lot less stress! 😊 #EXTEDO #HealthBoostDay

Have You already registered for the 9th Healthcare Symposium? Arvato Systems invites all IT Professionals and users in the pharmaceutical industry to Berlin to learn together about “Empowering Pharma with Data and AI: Simplifying the Complex”. If you are ready to shape your organization’s digital future, register now to meet the experts from Arvato Systems, EXTEDO, ROTE LISTE®, regenold GmbH, and many more. Together, we will discover the possibilities of AI and Data Management and discuss its implications. Use the opportunity to gain exclusive expert knowledge to streamline your processes and maximize efficiency throughout your organization! Participation is free of charge – register here: https://lnkd.in/dPhgUk_i What else can you expect? - Interactive Panel Discussions about AI in the Pharmaceutical Supply Chain and what topics should be on your digital agenda - Deep-dive breakout sessions on DTx and ePILs - Plenty of networking opportunities with leading minds in the industry, e.g., during an exclusive evening event at the Bertelsmann Representative Office We are looking forward to seeing you there! #EXTEDO #EXTEDOpulse #ArvatoSystems #ROTELISTE #regenold

We are pleased to present you with the latest episode in the Regulatory Executive Podcast Series, hosted by Gens and Associates Inc.! For this episode, Steve Gens MSOD invited our CEO, Martin Schmid, to discuss what EXTEDO is working on and what we have in store for our industry and agency customers. Get a fresh update on EXTEDO's activities and learn more about: - The new possibilities that are opening up to us thanks to our new shareholder, Bertelsmann Investments, who is working with us on a sustainable long-term partnership - What we are doing to live up to our corporate values and prioritize "customer first" -How we focus on important future topics, e.g., supporting the national authorities even more, our comprehensive solution offerings, or the use of Artificial Intelligence (AI) ... and what Steve Gens thinks of us calling ourselves "the trusted bridge between agency and industry."   Listen to this episode here https://lnkd.in/dwyaW86C and let us know what you think about it in the comments! We are looking forward to hearing from you! ;)     #EXTEDO #EXTEDOpulse

As a leading Regulatory Information Management (RIM) System vendor with our comprehensive solution EXTEDOpulse, we are constantly dealing with the multiple possibilities and benefits it offers to our customers. A RIM supports organizations on various levels – some regard it as their guarantee for peace of mind, as the driving force behind seamless document management and effortlessly compliant submissions, as their steadfast ally who does the regulatory legwork, or as simply a competitive advantage. But what is a RIM to people who work with it every day? Keith Wallace, our SVP Customer Care, continues the series. He and his team constantly focus on our customers and, thanks to their expertise, always offer a helping hand to ensure that processes run smoothly and business goals are reliably achieved. This is what Keith told us: “For me, RIM is the structured and systematic management of regulatory information throughout the product lifecycle. Our clients are tasked with handling a vast volume of documents and associated information, staying on top of submissions globally, and executing these tasks efficiently while adhering to regulations and meeting crucial timelines. With EXTEDOpulse, we provide a comprehensive RIM solution, as well as relevant services, via our Global Customer Services team, supporting our customers in implementing and operating an RIM system. With our SaaS solution, we even take over the heavy lifting of operating the required IT infrastructure so that our customers can concentrate on their core business.” Thank you for your time, Keith! If you would like to join Keith’s team and accompany our clients on their path to regulatory excellence, check out our current job offers: https://lnkd.in/dvwijWFr #EXTEDO #EXTEDOpulse #RIM

Join us at the 9th Healthcare Symposium hosted by Arvato Systems to learn about “Empowering Pharma with Data and AI: Simplifying the Complex” - Are you unsure how a pharmaceutical company can make the most of AI technology in its regulatory, logistical, and manufacturing processes? - Are you looking for an expert deep dive into digital therapeutics (DTx)? - Would you like to learn how electronic product information leaflets (ePILs) can streamline processes and improve the delivery of information to patients? If you answer at least one of these questions with “Yes”, the 9th Healthcare Symposium is the perfect event for you! Date: 10 - 11 September, 2024 Place: Berlin, Germany More info and registration: https://lnkd.in/duj6C3rw (Participation is free of charge.) Listen to inspiring presentations from industry experts, participate in interactive discussions and use the opportunity to network with like-minded professionals during an exclusive evening where it is less about the right technology but the right amount of luck… Together with Arvato Systems, ROTE LISTE®, regenold GmbH and other partners, we are looking forward to greeting you to shape our digital future together! #EXTEDO #EXTEDOpulse #ArvatoSystems #RoteListe #regenold