Expedited Pathways Center of Excellence
Speed your time to market with expedited programs from the FDA. To get new drugs to market and help seriously ill patients faster, FDA’s expedited programs allow pathways that compress the timelines for development and evidence gathering processes. Each program provides a different approach for accelerating complex regulatory processes.
Our Expedited Pathways Center of Excellence includes cross-functional experts in non-clinical, clinical, chemistry, manufacturing and controls and regulatory affairs to provide guidance and solutions to help you realize the full benefits of these expedited programs.
Tailored approaches to guide expedited programs
- Cross functional team of subject matter experts assigned based on specific product and development program
- Gap assessment or development plan creation
- Develop regulatory pathway strategy
- Support for formal FDA interactions
- Regulatory document development and submission support throughout product lifecycle