Day: March 13, 2026

NDA Regulatory Affairs in 2026: Key Processes, Documents, and RA Responsibilities

NDA Regulatory Affairs

NDA regulatory affairs work turns science into a review-ready submission. An NDA is the formal FDA marketing application for a new drug. FDA first runs a filing check within 60 days to confirm completeness. Then the team reviews the dossier. The CTD’s five-module structure, delivered through eCTD, improves consistency, traceability, and lifecycle management during review.

Sampling Plan in Pharma: GMP, FDA/EMA Expectations, and QC Workflow

Sampling Plan

A pharmaceutical sampling plan ensures that tested samples truly represent the entire batch. Because results determine product release, regulators require representative collection, justified sample size, controlled handling, and full documentation. Strong sampling practices reduce risk, support compliance, and protect patient safety.