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