New Drug Applications (NDAs)

PharmaReg offers comprehensive regulatory support for NDAs from meeting requests, Dossier Preperation, eCTD submission to Deficiency responses.

Our Regulatory Services Include:

• Pre-IND Meeting Requests

• PDUFA Fee Waiver Requests

• Pediatric Study Plan/Waiver Requests

• Orphan Drug Designations

• Priority Review Requests

• NDA Compilation and Preparation

• Labeling and SPL Creation

• eCTD Compilation and Submission

• Life Cycle Management