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

• パンフレット：From Protocol to Submission: Essential Regulatory Writing Resources
• 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
• Factsheet: CoAuthor | Factsheet

コンテンツ | Initial Clinical Trial Application:

• Factsheet: 規制対応と薬事申請コンサルティング
• ブログ：Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation

コンテンツ | Mid-Stage Development

• 論文: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• 事例：テクノロジーを駆使したオーサリングで患者ナラティブに変革をもたらす
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products

コンテンツ | Post Marketing:

• ブログ：Categorizing & Managing Risks in Aggregate Safety Reports
• White Paper: DSURs, RMPs, and PSURs – The Harmonization of Pharmacovigilance Documents
• On-demand webinar: RAPS Sponsored Webcast: Author Clinical Study Reports with Data Privacy & Disclosure in Mind
• ブログ：Expert Answers to Your Questions on Developing EMA Policy 0070 Submissions