Industry Trends10 min
Digital Transformation in Regulatory Affairs: Beyond Paper-Based Processes
How pharmaceutical companies are transitioning from paper to digital-first regulatory operations.
Nov 10, 2025Read Article →
Guides, templates, and insights to help you navigate the future of AI-powered pharmaceutical submissions.
Top picks to get you started with regulatory automation
Learn how to generate NDA, BLA, ANDA, and MAA submissions 75% faster. Complete guide for regulatory teams.
Step-by-step workflow for generating FDA New Drug Application (NDA) submissions with AI automation. Covers all 5 eCTD modules.
Master FDA supplements (CBE, PAS) and EMA variations (Type IA/IB/II) for post-approval changes with AI automation.
Complete guide for responding to FDA IRs, EMA Day 120/180 questions, and PMDA queries with AI-powered draft automation.
Understanding how multi-modal AI models like Claude, Gemini, and OpenAI GPT extract tables, charts, and figures from PDFs.
Insights on AI, regulatory affairs, and pharmaceutical innovation
How pharmaceutical companies are transitioning from paper to digital-first regulatory operations.
Learn about the most common eCTD validation errors that delay submissions and proven strategies to prevent them.
Analysis of potential time and cost savings from AI-powered eCTD submission automation.
Common questions about eCTD hyperlinks, validation, and compliance across global agencies.
The future of autonomous regulatory operations - from assistive to fully agentic AI.
How to manage multiple client submissions with zero cross-contamination risk.