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AIを活用したソリューションで規制文書を効率化

Accelerate the preparation & submission of crucial regulatory documents

The demands of pharmaceutical regulatory writing can be overwhelming with countless hours spent on compiling, reviewing, and formatting documents. Mistakes in this critical process can lead to significant delays in drug approvals, thus impacting patient care.

The emergence of artificial intelligence (AI) has brought new opportunities to streamline medical writing processes. However, implementing AI into regulatory writing requires an industry-specific approach beyond everyday AI applications’ basics. Regulatory documentation’s complexity and high stakes demand tailored AI solutions that ensure accuracy while enabling efficiency.

This white paper explores how organizations can deploy AI safely and securely to enable efficiency while ensuring accuracy.

Key benefits of AI in regulatory writing

  1. Automated workflows: Free up your team’s time by automating routine tasks and document formatting.
  2. Increased compliance: Ensure every document meets regulatory standards with AI-generated accuracy.
  3. Accelerated submission: Accelerate the preparation and submission of crucial regulatory documents.

What you'll learn

Strengths and weaknesses of generative AI software
How to ensure data privacy and security
Quick tips when using AI in regulatory writing

Download the white paper

Complete the form to download a copy of the white paper and learn how to transform regulatory writing with tailored AI software.

著者について

Sean McGee, MS

Director of Product

Christopher Kutzler

Product Manager

Certara(サターラ)について

サターラは、創薬と医薬品開発の変革のために尽力しています。We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

創薬からマーケットアクセス、商業化に至るまで、お客様の最も差し迫った課題に対応するためのソリューションをご提案致します。戦略的リーダーシップと高度なシミュレーション技術により、サターラは医薬品開発プロセスの最適化、リスク低減、結果の改善を実現する包括的なソリューションを提供しています。Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

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