If you are applying for Priority Review, you're hoping for the quickest possible approval decision. But if you are successful, you'll only have half the time to prepare for an Advisory Committee meeting.
Working with ECG’s Principals on BLA / NDA / PMA messaging, issues, and resolutions will ensure that your submission tells your product's story accurately, fully, and persuasively so its approval process is not unnecessarily delayed.
ECG facilitates Priority Review preparation by:
- Improving the filing document and assuring its consistency
- Constructing the strongest scientific arguments for approval
- Helping manage communication with the FDA
- Planning for shortened timelines
- Elongating working time should an Advisory Committee meeting become necessary
Allow us to add efficiency and effectiveness to document development and communication processes in order to meet the time and quality demands of a Priority Review.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information about how we can support your upcoming Priority Review preparation.
