EXTEDO provides software and expertise to efficiently manage regulated data, documents, and processes within the life science industry. The company helps organizations minimize compliance risks and accelerate the time-to-market for medicinal products, self-described as a provider of regulatory information management solutions.

EXTEDO

EXTEDO | 8,038 followers on LinkedIn. EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM) #wearehiring | EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and provide solutions covering the entire regulatory landscape:

Master Data Management
Content Management
Quality Management 
Product Registration (XEVMPD &amp; IDMP)
Submission Management (eCTD, RPS, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex)
Pharmacovigilance Management and Drug Safety (SUSAR, ICSR, PSUR, DSUR, E2B, MedDRA, SMQ, GVP, CIOMS, MedWatch, R3) 

Today, EXTEDO enables around 35 regulatory authorities and 1000 maintained customers across 65 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organizations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences.

Project Managemet Team Lead at EXTEDO

Miroslav Teur

Senior Vice President at EXTEDO

Keith Wallace

Account Manager at EXTEDO GmbH - Helping Life Science companies to ensure effortless compliance throughout the entire eRegulatory business process.

Terry Ivereigh

Procurment Accounting and Chinese Languauge Specialist

Prabha 李奕竹 Lalwani Jethwani

Mastering eCTD v4.0: Get Your Questions Answered! Join us for a special webinar designed around you! This is not your typical presentation - this live Q&A session is entirely driven by the questions you bring to the table. 🗓 Date: 03 December 2024 ⏰ Time: 4 PM CET | 10 AM EDT Registration: https://lnkd.in/dnbxhvPN 📌 Duration: 60 minutes Shape the agenda with questions that matter to you: To ensure your voice is heard, submit your questions by 22 November via e-mail ( info@extedo.com ). Led by Anjana Pindoria-Rettenberger , Director of Product Strategy at EXTEDO and our Masterclass eCTD v4.0 teacher, this interactive session offers the chance to: - Gain clarity on eCTD v4.0 - Discover expert insights on technicalities and future implications. Register now and be part of the conversation - your question could unlock insights for everyone!

Empower Your Compliance Strategy for Australia & South Africa and be part of the final session in our webinar series on DMF Submissions! In this complimentary webinar, “DMF and API MF Compliance in the Southern Hemisphere: A Focus on Australia and South Africa,” our expert speakers will discuss the unique regulatory requirements and compliance strategies essential for these high-impact markets. Date: 19 November 2024 Time: 16:00 CET | 10:00 EDT Registration: https://lnkd.in/dYRMxrJB Led by Priya Krishnan - MBA Engineering in Life Science Management , Frank Dickert , and Michael Faust - Business Consultant for Regulatory Affairs , you’ll learn: ✅ Australia’s Drug Master File (DMF) essentials ✅ South Africa’s API Master File (API MF) expectations ✅ How to leverage the Certificate of Suitability (CEP) ✅ Comparative insights to optimize compliance in each region Close the loop on DMF mastery with insights from this dynamic, expert-led series and master DMF compliance for Australia and South Africa. Can't make it live? Register anyway for access to the full recording! #EXTEDO #EXTEDOpulse #DMFsubmission #SAHPRA #TGA

We bid farewell to AfriSummit with a few impressions from the event's eCTD workshop, which we had the honor of sponsoring. Together with the esteemed participants, we discussed the intricacies of eCTD submission formats, regulatory requirements, and best practices. The program included vital components of eCTD preparation, validation, and submission, through which our trainer, Michael Faust - Business Consultant for Regulatory Affairs , patiently and enthusiastically guided us. The attendees' active participation and willingness to engage with this topic made it a special experience for him as well. This year's PharmaRegAfriSummit was again a unique time for the entire EXTEDO team. We learned, laughed, and exchanged a lot. We are delighted with the many valuable and inspiring contacts we made. In addition, two of our experts were able to share their knowledge with the regulatory professionals in attendance: Dr. Andrea Striebel , who spoke about AI and automation in safety management in the pharmacovigilance training, and Michael Faust, who discussed the need for data consistency in his talk. This was only possible thanks to the tireless work of the wonderful teams from Hubplus Events and PRA Consultancy , who, under the leadership of Dr. Mona Al Moussli , created an outstanding event. We thank them from the bottom of our hearts for allowing us to participate and look forward to seeing all of you again soon! #EXTEDO #EXTEDOpulse #eCTD #AfriSummit #PRAConsultancy #HubPlus

Stay Ahead of Key Regulatory Priorities: PMS, ESMP, and More! Join our complimentary webinar, "Regulatory Priorities: Essential To-Dos and Timelines for PMS, ESMP, and More," to learn how to navigate the upcoming challenges related to IDMP. Discover actionable timelines and essential steps and learn how to navigate these pressing regulatory developments confidently! Date: 14 November 2024 Time: 10:00 - 11:00 AM CET | 04:00 - 05:00 AM EDT Registration: https://lnkd.in/ddJZBEay Key Topics Covered: • PMS (Product Management Service) • ESMP (European Shortage Monitoring Platform) • eAF (electronic Application Form) Dr. Anna Thaidigsmann , Principal Business Consultant at EXTEDO, will guide you through the necessary steps and provide valuable insights on how and when to prepare. Register today to secure your place and stay up to date. Can't make it live? Register anyway and get the recording! #EXTEDO #IDMP #PMS #eAF

We would like to share only two of our highlights at PharmaRegAfriSummit 2024. We are very happy about the many years of fruitful and highly professional cooperation with the initiators of AfriSummit, PRA Consultancy , and Hubplus Events . We are all the more proud and grateful to receive an award for our commitment as a sign of mutual recognition, which was presented to our team in the presence of Dr. Mona Al Moussli . Michael Faust - Business Consultant for Regulatory Affairs 's presentation was also about collaboration: He talked about data silos and the importance of breaking them down to take an organization's regulatory processes to the next level - both in industry and in government. Tomorrow, Michael will share his knowledge with the esteemed participants of the eCTD training, guiding them through the key components of eCTD preparation, validation, and submission. We wish all participants an inspiring time!

Are you ready to master DMF submissions in the US and Canada? Well, if you think you need a refresher, don't miss our free webinar: "The Tiny but Mighty Differences of DMF Submissions: US FDA vs Health Canada Use your chance to register and gain valuable insights to boost your DMF expertise! Date & Time: November 7, 2024 | 16:00 CEST | 10:00 EDT More information and registration: https://lnkd.in/dfxQrg2d Join our experts Sylvie COLIN , Iqra Ali , and Ian Lake to learn more about: ✅ Key requirements for US FDA DMF submissions ✅ Specific Health Canada expectations and common pitfalls ✅ Comparison of US and Canadian processes to boost your submission strategy Secure your spot today - if you can’t make it live, register to receive the recording. We are looking forward to greeting you! #EXTEDO #EXTEDopulse #FDA #HealthCanada

We’re thrilled to be part of the PharmaRegAfriSummit 2024 in Cairo! Today marks the first day of this premier regulatory conference hosted by PRA Consultancy & Hubplus Events and we’re excited to connect with industry leaders and regulatory authorities from across Africa and beyond. Visit us at our booth to learn how EXTEDO’s innovative life sciences solution offering can support your organization in achieving compliance and streamlining regulatory processes. This is a great opportunity to engage directly with regulatory authorities and discuss how we can collaboratively navigate the evolving regulatory landscape in Africa. Whether you're looking to streamline your business processes or enhance compliance, our team is here to provide answers and showcase our solution offering.

The Shadows of Compliance Once upon a midnight dreary, Regulatory tasks grew eerie, Audits, filings stacking near me, Threatened chaos - evermore. But from the dark, a light was glowing, EXTEDOpulse, its strength bestowing - “Fear not,” it whispered, ever-knowing, Guiding me through every door. “Fear not,” it whispered, “Evermore.” Master Data, calm and steady, SPOR-aligned, precise, and ready, Brought my data clear and steady, Lost in chaos - nevermore. Documents once brought confusion, Now, in order, no illusion. With EXTEDOpulse's swift infusion, Filing fears exist no more. "Automated," it softly whispered, “Fear this burden nevermore.” IDMP, that looming terror, Fell to Registration’s bearer. One source of truth, no room for error - EXTEDOpulse my strong rapport. “Stay your course,” it calmly murmured, “Fear these shadows nevermore.” Safety threats began to scatter, EXTEDOpulse - no risk would matter. PSUR reports in order, Fear of standards gone before. “Vigilant,” it ever promised, “Fear this chaos nevermore.” Submissions stacked, the final test, EXTEDOpulse had done the rest. Global markets all addressed, And compliance burden- nevermore. 🎃No matter how dark the shadows of compliance are, we are here to see you through them! To learn more about EXTEDOpulse and how it can illuminate your regulatory processes, please go to https://lnkd.in/dRKu-A-U Happy Halloween! #EXTEDO #EXTEDOpulse #HappyHalloween

Boost Compliance and Case Analysis with the Power of Business Intelligence (BI)! Meet the SafetyEasy™ Business Intelligence Module - your go-to solution for comprehensive data analysis and enhanced compliance in drug safety. How you benefit from the SafetyEasy™ Business Intelligence Module: 🌐 Gain a 360° dynamic view of your scientific data, helping you detect safety signals more effectively. 🚀 Supercharge your data analysis and reporting capabilities with Qlik Sense technology, which is even trusted by the US FDA. 📈 Improve compliance with global regulations, from EMA and US FDA to ICH and beyond, while streamlining your KPI tracking and reporting workflows. The BI Module enables you to make data-driven decisions, ensuring your organization stays ahead of evolving safety regulations, all while increasing operational efficiency. Are you ready to enhance your compliance and analysis processes? Discover how SafetyEasy™ and its BI Module take your drug safety management to the next level: https://lnkd.in/d33GXruY #EXTEDO #EXTEDOpulse #SafetyManagement #AI #Pharmacovigilance #QlikSense #FDA

Meet the newest member of our team: Julia Schlederer Julia brings extensive experience in quality management and a strong background in optimizing technical processes. Her expertise in maintaining and improving quality standards will be key to ensuring our continued excellence. Having worked in the radiopharmaceutical industry, Julia has developed valuable skills to support the growth and development of our quality processes at EXTEDO. "The first few weeks in my new company have shown me that a strong team not only works together but also supports and appreciates each other. I am grateful to be part of such a warm and motivated team." We're glad to hear that and are excited to have you on board, Julia Schlederer! ☑️ Interested in making a difference? Learn more about our current opportunities and become an #EXTEDORIAN : https://lnkd.in/ddhcvEg8 #EXTEDO

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