From pilot to production: closing the confidence gap
AI is now firmly on the regulatory writing agenda. Tools are being tested, investments are being made, and expectations remain high. Yet many organisations struggle to move beyond pilot and into confident, scalable use.
Bioscript Group commissioned The State of AI in Regulatory Writing 2026 to investigate the gap between anecdote and evidence with the aim of establishing an independent, practitioner-led benchmark of how AI is actually being applied in regulatory writing today.
Drawing on insights from nearly 300 regulatory professionals across more than 15 countries, spanning pharma, CROs, regulatory authorities and consultancies, the report provides an evidence‑based view of AI adoption and maturity, where it is delivering value, and what is constraining scale.
What the report examines
The findings explore:
- How real-world AI adoption in regulatory writing compares with maturity across organisations
- Where AI is delivering measurable benefit — and where expectations outpace reality
- Why confidence, governance and validation remain central barriers
- What’s required to move from experimentation to trusted, scalable use
Why this matters
As AI becomes a permanent feature of regulatory writing, decisions about its use must be defensible, governed and aligned with regulatory expectations. This report is designed to support informed decision‑making for teams navigating the transition from pilot to full integration.
This report reflects Bioscript Group’s ongoing commitment to evidence‑based insight in regulatory writing.
Access the full report below.
