Senior expertise combined with modern AI tools for faster, high-quality regulatory documents
ESW Communications combines 20 years of regulatory writing expertise with modern AI tools to deliver high-quality documents faster—without compromising the scientific rigor and compliance your submissions require.
AI assists with first drafts, consistency checks, and formatting—but every document is written, reviewed, and finalized by an experienced regulatory medical writer. You get the efficiency of modern tools with the quality assurance of human expertise.
AI tools accelerate routine tasks, allowing us to focus more time on the strategic and scientific work that makes submissions successful.
AI-assisted drafting accelerates initial document creation, giving us more time for critical review and refinement.
AI tools check for internal consistency, cross-reference accuracy, and formatting compliance.
Automated checks ensure consistent use of terms and abbreviations across lengthy documents.
AI tools help manage workload peaks, so your timelines don't slip when demands increase.
A transparent process that combines AI efficiency with human expertise at every step
Every project begins with an experienced writer understanding your goals
Modern tools accelerate first drafts while maintaining structure
All content is critically reviewed and refined by a senior writer
AI-powered consistency checks complement traditional QC
Every deliverable reviewed and approved by an experienced professional
All of our core services benefit from AI-assisted workflows:
ICH E3-compliant CSRs for Phase I–IV studies
Clinical overviews, clinical summaries, nonclinical overviews
ISS/ISE development and cross-study analyses
Comprehensive IB development and updates
IND, NDA, BLA, MAA support
Health Authority queries and briefing documents
SAE, death, and discontinuation narratives
Manuscripts, abstracts, posters
ESW Communications has invested in formal AI training to ensure our workflows meet the compliance and quality standards expected in pharmaceutical regulatory submissions.
Enrolled in the Drug Information Association (DIA) course "Transforming Regulatory Affairs with Generative AI: Practical Integration for Smarter, Faster Outcomes" — covering prompt engineering, regulatory applications, quality assurance, and ethical AI use.
AI is used as a drafting and quality-checking tool—not as the author. All content is written or substantially revised by an experienced regulatory medical writer, ensuring it meets the same standards as traditionally authored documents.
We use enterprise-grade AI tools with appropriate data protections. Sensitive study data and proprietary information are handled according to your confidentiality requirements, with options for local processing when needed.
No. AI accelerates routine tasks, but regulatory medical writing requires scientific judgment, regulatory knowledge, and strategic thinking that only comes from experience. AI makes our work more efficient—it doesn't replace the expertise.
Current regulatory guidance does not require disclosure of AI-assisted drafting tools, similar to how spell-checkers or reference managers don't require disclosure. We stay current with evolving guidance and can discuss specific requirements for your submission.
Contact us to discuss how AI-enhanced regulatory writing can support your next project.
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