Imvax accelerates document reviews for faster regulatory approval

The challenge

Imvax’s expertise in biopharma development is matched by its dedication to delivering therapies for solid tumors. With an increasing number of documents to review during regulatory filings, Imvax needed a streamlined way to manage feedback, ensure consistency, and keep review cycles on track, especially for their FDA filings.

Imvax’s paper-based document review system created inefficiencies and frustrations across teams. Version control issues, missed deadlines, and lack of visibility into the review process hampered their ability to stay on track. This led to missed timelines and rework, which became increasingly difficult as the company prepared for major regulatory submissions. 

The solution

With past experience using Ideagen PleaseReview, Imvax’s Program Management team knew the software could resolve their challenges. Ideagen’s ability to assign sections to specific reviewers and track real-time changes made it an ideal solution for managing critical FDA documents.

The implementation

With Ideagen PleaseReview in place, Imvax quickly saw an improvement in their ability to manage complex, high-stakes documents like those required for FDA filings. Reviews became faster and more disciplined, allowing the company to stay on schedule and ensure all regulatory requirements were met: 

• Enabled real-time collaboration across multiple functions and time zones, improving team communication. 
• Automated activity tracing and accountability features helped keep document reviewers on track. 
• Simultaneous review capabilities allowed cross-functional teams to work on the same document, saving valuable time.

The outcome

Ideagen PleaseReview provided Imvax with the stability, control, and efficiency they needed to meet deadlines and stay compliant with FDA regulations. With this solution, they are well-positioned to continue delivering life-changing therapies to patients faster. 

• Document review cycles reduced by 65%, keeping projects on schedule. 
• Enhanced collaboration, allowing teams to work on documents simultaneously and resolve issues in real-time. 
• Improved document consistency, eliminating version control issues across the organization.