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

• Brochure: From Protocol to Submission: Essential Regulatory Writing Resources
• Schedule a CoAuthor Demo: Life Science Specialized GenAI for Regulatory Writing
• Factsheet: CoAuthor | Factsheet

Resources | Initial Clinical Trial Application:

• Factsheet: Regulatory Consulting and Regulatory Affairs
• Blog: Authoring & Assembling IND & CTA Applications – Insights & Updates
• White Paper: New EU Clinical Trial Regulation

Resources | Mid-Stage Development

• Publication: Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
• Case Study: Changing the Narrative on Narratives Using Technology-Enabled Authoring
• White Paper: Avoid & Fix Common Errors in Regulatory Submissions for Drug Products 

Resources | Post Marketing:

• Blog: 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
• Blog: Expert Answers to Your Questions on Developing EMA Policy 0070 Submissions