The demands of pharmaceutical regulatory document creation can be overwhelming—countless hours are spent compiling, reviewing, and formatting content. Even small mistakes in this critical process can cause costly delays in drug approvals, ultimately impacting patient care.
The emergence of artificial intelligence (AI) software for regulatory document development has opened new opportunities to streamline regulatory and medical writing. However, effectively implementing AI tools for regulatory writing requires more than generic AI applications—it demands an industry-specific approach built for the complexity and precision of pharmaceutical submissions.
Discover how Certara is transforming the future of medical and regulatory writing with an industry-focused GenAI software for regulatory writing. This white paper explores how your organization can safely and securely deploy AI writing solutions to boost efficiency, ensure accuracy, and maintain full compliance with regulatory standards.
Download the free white paper to learn how AI can accelerate and simplify your regulatory writing process.
Key Learnings for Medical Writers:
- Strengths and weaknesses of generative AI software in regulatory contexts
- How to ensure data privacy and maintain document security
- Practical tips for safely using AI writing solutions in the pharmaceutical industry
Transform Your Regulatory Writing Process:
- Automated Workflows: Free up your team’s time by automating repetitive writing, editing, and formatting tasks.
- Increased Compliance: Ensure every submission-ready document meets stringent global regulatory standards with AI-powered accuracy.
- Accelerated Submission: Speed up preparation and submission timelines for critical regulatory documents.
Discover how leading organizations have successfully integrated Certara’s CoAuthor™, a purpose-built AI writing solution for the pharmaceutical industry, to improve document quality and shorten approval timelines from regulatory authorities.
Complete the form to download your free white paper and learn how tailored AI software for regulatory document writing can transform your submission process.
About the authors
Sean McGee, MS
Director of Product
Sean McGee is currently the Director of Product at Certara, working within the Certara artificial intelligence (AI) group. Throughout his career, Mr. McGee has supported the strategy and go-to-market motions of various software technologies, including Benchling’s laboratory informatics platform and the AI and molecular modeling and simulation offerings for Dassault Systèmes BIOVIA brand. In his role with Certara, Mr. McGee guides the development of new AI-focused use cases which maximize the benefits of the Certara AI and broader company portfolio.
Christopher Kutzler
Product Manager
At Certara, Christopher Kutzler has over six years of experience working with and helping build eCTD submission and medical writing software. As Product Manager, Chris excels at transforming user challenges into actionable features and keeping a customer-focused approach to each solution brought forward.
