TRI has enabled our company and clients to radically improve regulatory records management, publishing and submission through commercial and custom regulatory management solutions. With expert input and guidance from our Regulatory Affairs management and in-house industry experts, our IT services remain flexible, compliant and current with emerging trends.
Our commercial, off-the-shelf solutions are built on LIQUENT InSight® and support the management of over 3000 IND submissions each year. Centralizing regulatory dossiers, effective templates and process automation improve quality and efficiency through reusable content and built-in compliance checks throughout the process.
Our solutions include:
- Full validation for Part 11 compliance
- A zero footprint web client
- Wizard-driven workflows for assembly, review and submission
- Transparent submission planning and tracking
- eCTD and NeeS dossier formats
- Automated eCTD validation checks against current FDA validation criteria
Combining our IT and Regulatory Affairs expertise, TRI has helped many clients plan and execute a transition to electronic submissions while managing the complexities of large networks and inconsistent source materials. TRI’s unique synthesis of software-based solutions and regulatory expertise makes us the ideal partner for any organization looking to optimize their registration and submission process.