The Challenge
This rapidly growing biotech company had three promising oncology drugs in late-stage clinical trials. Their regulatory operations team of 12 was struggling to keep pace with the submission demands.
Key Challenges
- Manual eCTD validation taking 3-4 days per submission
- Last-minute errors causing weekend work and team burnout
- Two technical rejections in the past year, delaying approvals
- Audit preparation requiring 3+ weeks of document gathering
- Version control issues leading to wrong documents in submissions
We were growing fast, but our submission process wasn't scaling. Every submission felt like a crisis. My team was burning out, and I was losing sleep over potential FDA rejections.
The Solution
After evaluating several regulatory technology platforms, the company selected DNXT Publisher Suite for its comprehensive validation capabilities, intuitive interface, and proven track record with similar biotech companies.
DNXT Implementation
- Automated Validation: Real-time eCTD validation as documents are added, not just at submission
- Document Management: Centralized repository with version control and audit trails
- Workflow Automation: Configurable review and approval workflows
- Multi-Region Support: Single platform for FDA, EMA, and Health Canada submissions
The implementation was completed in 8 weeks, with the team fully trained and processing their first submission through DNXT by week 10.
The Results
Within six months of implementation, the regulatory operations team saw dramatic improvements across every metric they tracked.
Measurable Outcomes
- 70% faster submission prep: From 12 days to 3.5 days average
- Zero technical rejections: 18 months and counting
- 98% first-time acceptance rate: Up from 82%
- Audit prep reduced to 2 days: Down from 3 weeks
- $1.2M annual savings: From efficiency gains and avoided delays
DNXT transformed our regulatory operations. What used to take days now takes hours. My team has gone from firefighters to strategic partners.
Key Success Factors
- Executive sponsorship: VP of Regulatory championed the project from day one
- Phased rollout: Started with validation, then added document management
- Power user training: Two team members became internal DNXT experts
- Process alignment: Updated SOPs to leverage automation capabilities
Looking Ahead
The company is now expanding their use of DNXT Publisher to include AI-assisted document classification and is piloting the platform's analytics dashboard for submission planning.
