EXTEDO

Ukraine goes eCTD! Are you ready to validate your submissions? With EXTEDO’s EURSvalidator, you can validate even several submissions at the same time to ensure they comply with the latest regional requirements. By providing guaranteed up-to-date validation sets, EURSvalidator is ready to support your submission to the Ukrainian authorities, thanks to… - Proactive involvement of EXTEDO experts with the Ukrainian agency to understand the validation rules - Multiple releases per year that include the latest changes in the requirements - A dedicated validation set for Ukraine that can easily be combined with other regional sets within one subscription More than 30 national competence authorities trust in EXTEDO solutions today. When will you? If you need more reasons to convince yourself of the powers of EURSvalidator, go to https://lnkd.in/dpRggj3k or contact us! #EXTEDO #EXTEDOpulse #EURSvalidator #Ukraine #eCTD

Tired of Regulatory Submission Publishing Headaches? With EXTEDO’s Regulatory Submission Publishing Team, you can rely on timely services and compliant regulatory submissions. Working on two continents, our dedicated team covers 14 hours of the day to provide you with regulatory excellence. A wide range of clients already trusts our experienced publishers, e.g., argenx, who says about our collaboration: "Their staff helped us to complete our first submission and get the application approved within a very demanding timeline." - Kristien van Nimmen, Director Regulatory Operations, argenx Get ready to experience the quality of EXTEDO’s Regulatory Submission Publishing Services and enjoy a discount for your first submission: - 15% off for the first EU submission - 20% off for the first US submission plus: 2 hrs of Submission Training! Request your individual offer: https://lnkd.in/dBpvdSsc #EXTEDO #EXTEDOpulse #Submission #eCTD #StopSubmissionFrustration

EXTEDO is thrilled to be a Workshop sponsor at PharmaRegAfriSummit once again this year! In this exclusive interview, our CEO, Martin Schmid, tells you how we align our solutions and training offers with the needs of our customers and, of course, what it means for us to be present at this exceptional event. PS: Martin will be present at AfriSummit as well. If you spot him there, just say hello and tell him that we say "hi" ;) #EXTEDO #EXTEDOpulse #eCTD #AfriSummit #eCTDAfriSummit #PharmaRegAfriSummit

Ukraine goes eCTD! Are you ready to manage your submissions? With EXTEDO’s eCTDmanager, you can effortlessly build and publish your submissions while staying compliant with international regulatory requirements. By implementing the Ukrainian eCTD requirements and validation sets, eCTDmanager is ready to support you with... - The Ukraine M1, combined with the already existing ICH M2 to M5 version 3.2 - The adaption of document file names automatically, where applicable - An included UUID generator - Pre-validation within the solution - In-built official technical validation after export We think complying with regulatory standards and processes worldwide should be effortless. What about you? If you need more reasons to convince yourself of the powers of eCTDmanager, go to https://lnkd.in/dqRx4Phd or contact us! #EXTEDO #EXTEDOpulse #eCTDmanager #Ukraine #eCTD

Are you curious how eDOCSmanager Quality helps life science organizations navigate regulatory requirements from the FDA, EMA, and beyond? Dive into the world of automated workflows, collaboration capabilities, and quality document management with this must-read interview. Click the link below to join the conversation and discover the ways eDOCSmanager Quality ensures compliance and efficiency in managing quality documents: https://lnkd.in/duSMifhQ. #EXTEDO #EXTEDOpulse

Meet the newest member of our team: Andrea Estrada Andrea Estrada brings valuable experience in digital marketing and brand building. Having worked in diverse environments, she has developed skills that will support our market visibility and further promote brand awareness. Her expertise in social media management, content creation, and digital campaign execution will be instrumental in driving our marketing efforts forward. "I am thrilled to join EXTEDO as a Marketing Specialist. The team has been incredibly welcoming, and I appreciate the open-minded and communicative culture here. I'm excited about the opportunity to leverage my experience in digital marketing to contribute to our marketing initiatives and help achieve our goals." We're glad to hear that and are excited to have you on board, Andrea Estrada! ☑️ Interested in making a difference? Learn more about our current opportunities and become an #EXTEDORIAN: https://lnkd.in/ds5QJb5n

Update on eCTD v1.0 Timeline for Singapore Singapore’s Health Sciences Authority (HSA) has announced a shift in the timelines for the eCTD specification package (v1.0). The release has been moved to Q3 2024 from the previously planned Q2 2024. Consequently, the implementation is now targeted for Q1 2025 instead of Q4 2024. Need to anticipate the content changes? Find more details in our blog post: https://lnkd.in/dg9XEn2m #eCTD #RegulatoryAffairs #Pharmaceuticals #Singapore #HSA

Join EXTEDO and Make a Global Impact! 🌐 We are hiring for exciting positions, e.g.: - Technical Consultant (Germany): https://lnkd.in/dK8-jYWZ - Pre-Sales Manager (USA): https://lnkd.in/dBHpkhq4 - Senior Software Engineer (Germany): https://lnkd.in/dFnHz8rt With over 25 years of innovation, 100+ employees, and 20+ nationalities, EXTEDO stands as a leader in Regulatory Information Management (RIM). Our diverse, dynamic team is united by a passion for making a positive impact on global healthcare. Why EXTEDO? - Modern working conditions & flexible models - Hybrid & full remote work options - Flat hierarchy & open-door policy - Comprehensive onboarding & training Join us in our mission to make the world a healthier and safer place for everyone. Be a part of something meaningful at EXTEDO! Check out our Careers page to learn more: https://lnkd.in/dyZmfdZV #EXTEDO # #Jobs #Hiring #HiringNow #LifeSciences #EXTEDOrian

EXTEDO Summer Party 2024 was a blast! 🌞 It was wonderful seeing everyone come together, reconnecting, and making new connections. The highlight of the day was undoubtedly our Farm Olympics – filled with games, laughter, and a healthy dose of friendly competition ;) We wrapped up the day with a delicious BBQ dinner, enjoying great food and even better company. Days like these remind us of the fantastic team we have and the amazing culture we've built together. Check out the photos to see some of the memorable moments we captured. Here's to celebrating more milestones and creating lasting memories together! #EXTEDO #EXTEDOSummerParty #teamevent #CompanyCulture 

There are only a few days left to register for our complimentary webinar, "Unlock the Benefits of EXTEDO Training Programs." Would you like to enhance your personal or team’s expertise with EXTEDO solutions? In this webinar, you will learn how our comprehensive training programs can help you leverage the full capabilities of EXTEDO solutions! Date: 16 July 2024 Time: 10:00 - 11:00 AM CEST | 04:00 - 05:00 AM EDT Registration: https://lnkd.in/dP-2YD_T Our expert speakers, Ralf-Peter Berg, Director of Training & Education, and Priya Krishnan - MBA Engineering in Life Science Management, Junior Business Consultant, will show you EXTEDO’s comprehensive Qualification Programme, which is based on three educational levels, as well as our eLearning platform, "EXTEDO Unversity." Experience the power of EXTEDO training and register today! Not sure if you can attend? Register anyway to receive the recording! For more EXTEDO events, check out our website: https://lnkd.in/dZzHzH5K #EXTEDO #EXTEDOpulse