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Transforming Regulatory Processes Through Artificial Intelligence Pharmaceutical companies are under increasing pressure to produce structured, high-quality Chemistry, Manufacturing, and Controls (CMC) documentation often under tight timelines. Manual authoring of CMC/Module 3 content remains a bottleneck due to the sheer volume, complexity, and regulatory scrutiny involved. Celegence’s latest whitepaper explores how Generative AI is reshaping regulatory […]
Make Sure You’re EU MDR Compliant As regulatory specialists, we are aware of the burden you are probably under in making your medical device business compliant with the upcoming EU MDR which comes into force later this year. As part of our commitment to helping businesses make the transition, we have compiled a checklist which […]
Make Sure You’re EU IVDR Compliant As regulatory specialists, we are aware of the burden you are probably experiencing in making your In Vitro Diagnostic device compliant with the EU IVDR which comes into force next year. The EU IVDR affects all IVD medical devices and will bring about several major changes. As part of […]
Lean Authoring: Eliminating Redundancies And Complexities For The Pharmaceutical Industry And Health Authorities
Download our exclusive report to streamline regulatory approvals and optimize your EU scientific advice strategy.
Get instant access to the survey report that regulatory professionals are talking about: the 2024 RAPS & Celegence Regulatory & Readiness Survey.
Be the first to explore pivotal findings that will shape the future of MedTech regulation. Our survey covered key topics such as current challenges, resource allocation, advanced technologies, and regulatory processes to provide a clear picture of where the industry is headed.
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Austrian Agency for Health and Food Safety (AGES)
Federal Agency for Medicines and Health Products (FAGG)
Bulgarian Drug Agency (BDA)
Agency for medicinal products and medical devices of Croatia (HALMED)
Ministry of Health – Pharmaceutical Services
State Institute for Drug Control (SUKL)
Danish Medicines Agency (DKMA)
State Agency of Medicines (Ravimiamet)
Finnish Medicines Agency (FIMEA)
National Agency for the Safety of Medicine and Health Products (ANSM)
German Institute of Medical Documentation and Information
National Institute of Pharmacy and Nutrition (OGYEI)
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December 4, 2025
October 21, 2025 | Berlin, Germany
June 26, 2025
March 26, 2025 | New Orleans
March 12, 2025 | Online
February 3, 2025 | North Bethesda , MD
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