イベント・学会参加情報
日にち
March 18-20, 2025
Location
Basel, Switzerland
Booth #F2
DIA Europe 2025
Visit Certara at Booth F2 in the DIA Europe 2025 in Basel, Switzerland | March 18-20, 2025
CoAuthor
Regulatory writing technology needs to be smarter, user-friendly, and collaborative—and CoAuthor delivers. It streamlines the process with fast template selection, structured content authoring, and generative AI within Microsoft Word.
- 275以上のeCTD準拠テンプレートにスタイルガイドを適用することで、文書のフォーマットに費やす時間を50%削減できます。
- 複合語から作用機序に関する段落まで、あらゆる文章をすべてのドキュメントで再利用できます。
- Leverage a biomedically-specialized GPT behind your firewall, for secure, prompt-based text generation
GlobalSubmit eCTD Platform
GlobalSubmit enables teams to manage the regulatory process so they can successfully publish, validate, and review eCTD submissions across a global footprint of regulatory health authorities.
- Create submissions that conform to any or all of 9 health authorities’ required structure, XML, and validation report.
- Review eCTD submissions across stakeholders prior to submitting
コンテンツ
サターラはライフサイエンス業界のイノベーターと連携することで、患者さんに医療を迅速に届けます。Together we advance modern drug development with biosimulation, regulatory science, and market access solutions. We use software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries.
From molecule to market, Certara is your trusted partner in the drug development journey. Backed by a team of experts and innovative technology, we’re here to guide and support you at every stage. Explore our expertly curated resources, and feel free to reach out with any questions.
AI Enabled Regulatory Writing
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Schedule a CoAuthor Demo: 薬事規制文書のための生成AIとライティングソフトウェア
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Factsheet: CoAuthor | Factsheet
- White paper: Streamline Regulatory Writing with AI-Powered Solutions | Certara
コンテンツ | Initial Clinical Trial Application:
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Factsheet: 規制対応と薬事申請コンサルティング
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White Paper: New EU Clinical Trial Regulation
- Factsheet: サターラ の戦略的早期開発ソリューション
コンテンツ | Mid-Stage Development
コンテンツ | Regulatory Science Operations
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On-demand webinar: GlobalSubmit Review and You: How to Expedite the Submission Review Process
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Factsheet: GlobalSubmit eCTD Platform
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Factsheet: Regulatory Operations | Certara
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Factsheet: Strategic Regulatory Affairs | Certara
コンテンツ | Post Marketing:
