Artos at RAPS Global Regulatory Strategy Conference 2025

Meet Artos's Team at the RAPS Global Regulatory Strategy Conference 2025 in Baltimore, MD

Join Artos to explore how our innovative AI driven workflows are supercharging regulatory document authoring. RAPS brings together a fantastic community of regulatory intersection professionals and with AI at the top of mind for most companies this year, we can't wait to participate in exciting discussions on:

• Latest GenAI technologies tailored for regulatory document authoring and QC/ review processes

• Identifying high impact use cases to build using AI for regulatory submissions

• Change management for AI adoption

• How AI fundamentally differs from structured content authoring

AI Tailored for Regulatory Workflows

Regulatory Operations demands tools that go beyond the capabilities of general-purpose AI. Artos’s platform is specifically designed to address the unique challenges of authoring documents as part of regulatory submissions for the electrical Common Technical Document (eCTD) format and medical writing, enabling life sciences organizations to:

• Automate repetitive tasks like document drafting, formatting, QC checks, and review.

• Generate consistent, high-quality documents across the CTD pyramid

• Ensure compliance with FDA and ICH (International Council of Harmonization) standards while improving the efficiency of submission workflows.

Empowering Regulatory Teams

Our advanced AI workflows support medical writers and regulatory professionals across all parts of the eCTD submission. Some examples of documents we support are listed below

• Module 2

  2.4 - Non-Clinical Overview

  2.5 - Clinical Overview

  2.6.2 - Pharmacology Written Summary

  2.6.3 - Pharmacology Tabulated Summary

  2.6.4 - Pharmacokinetic Written Summary

  2.6.5 - Pharmacokinetic Tabulated Summary

  2.6.6 - Toxicology Written Summary

  2.6.7 - Toxicology Tabulated Summary

  2.7.2 - Summary of Clinical Pharmacology

  2.7.3 - Summary of Clinical Efficacy

  2.7.4 - Summary of Clinical Safety

• Module 3

  3.2.S.1 - General Information

  3.2.S.2 - Manufacture

  3.2.S.3 - Characterization

  3.2.S.4 - Control of Drug Substance

  3.2.S.7 - Stability

  3.2.P.1 - Description/Comp. of Drug Product

  3.2.P.2 - Pharmaceutical Development

  3.2.P.3 - Manufacture

  3.2.P.5 - Control of Drug Product

  3.2.P.7 - Container Closure System

  3.2.P.8 - Stability

• Module 5

  5.3.5.1 - Clinical Study Report (Controlled)

  5.3.5.2 - Clinical Study Report (Uncontrolled)

Connect With Artos at RAPS Regulatory Strategy Conference 2025

Reach out to Mihikaa at mjain@artosai.com to set up a time to chat or connect on LinkedIn.