Case Study: a small biotechnology company achieves on-time IND and CTA submissions with Certara

Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management

A small biotechnology company with no prior regulatory experience faced significant challenges preparing its first Investigational New Drug (IND) application in the U.S. and Clinical Trial Application (CTA) in Canada. Key hurdles included a lack of understanding of regional requirements, no established internal processes for planning or tracking, and insufficient resources to coordinate the complex documentation and timelines needed for submission.

Certara provided integrated project management and regulatory submission leadership to address these challenges. Their solution included strategic planning, risk management with real-time tracking tools, and cross-functional meeting facilitation, alongside authoring and publishing support. As a result, the small biotech successfully submitted both the IND and CTA on time, established a repeatable workflow for future use, and advanced its product into first-in-human trials.