Articles tagged with “cta-submission”

AI for IND & CTA Drafting: Benefits, Risks & Compliance Guide

Learn how generative AI and LLMs assist in drafting pharma IND & CTA submissions. This guide explains the benefits, risks, GxP compliance, and FDA/EMA guidance.

60 min read

12/9/2025

generative ai regulatory affairs ind submission cta submission medical writing llms in pharma gxp compliance drug development fda guidance