RAPS Convergence 2025

RAPS Convergence turns 50 in Charlotte, and the regulatory profession has never faced a faster-moving landscape. Meet Certara at Booth 1019 to see how expert strategy and purpose-built technology help you navigate AI regulation, global submissions, and evolving health-authority expectations — so you can bring safe, effective products to patients, sooner.

RAPS exists to develop a competent global regulatory workforce that advances public health — a mission Certara shares. This year’s Convergence puts a spotlight on the forces reshaping regulatory affairs: generative AI and its oversight, increasingly complex global submission strategies, digital health, and the growing demand to align science, regulation, and business strategy. Certara meets those challenges with seasoned regulatory strategists and technology built for the way regulatory teams actually work. Stop by Booth 1019 to talk through your submission goals with the people and tools behind them.

From strategy to submission, we connect the dots the Convergence agenda is built around.

Set the strategy: Global Regulatory Strategy Consulting

Certara’s Global Regulatory Strategy Consulting team integrates regulatory intelligence into your development strategy, translating global frameworks — FDA, EMA, MHRA, PMDA, and beyond — into actionable local plans. From orphan and accelerated pathways to lifecycle management, our consultants help you reach regulatory milestones with confidence. The same team provides regulatory authoring and content-development support — from FDA and EMA meeting requests and briefing books to eCTD module summaries — delivered as an integrated part of your regulatory strategy. 了解更多

Write with human-at-the-helm AI: CoAuthor™

CoAuthor is Certara’s GenAI software for regulatory and medical writing. Built by writers, for writers, it pairs a purpose-built biomedical GPT with an eCTD template library and structured content authoring — right inside Microsoft Word — so teams draft consistent, compliant documents faster while keeping a human in the loop. It’s a working answer to the conference’s central question of how to adopt AI responsibly. 了解更多

Get to submission faster: GlobalSubmit™

GlobalSubmit is Certara’s eCTD software to publish, validate, review, and transmit submissions — eliminating risk and expediting regulatory acceptances. As global submission strategy grows more complex, GlobalSubmit keeps your dossiers compliant and submission-ready across regions. 了解更多

Explore best practices in regulatory strategy, submissions, and AI-enabled writing before you arrive.

• 战略性法规事务咨询服务
• CoAuthor™
• GlobalSubmit™