WHITE PAPER

Streamline Regulatory Writing with AI-Powered Solutions

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.

About the authors

Sean McGee, MS

Director of Product

Christopher Kutzler

Product Manager

About Certara

Certara is dedicated to transforming drug discovery and development for good. We harness the power of biosimulation, advanced analytics, and regulatory expertise to create a future where treatments reach patients faster and more efficiently.

From discovery to market access and commercial, we tailor solutions to meet our clients’ most pressing challenges. Through strategic leadership and advanced predictive technologies, Certara provides comprehensive solutions to optimize drug development processes, reduce risks, and improve outcomes. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.

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