Asphalion and Narrativa combined regulatory consulting with AI agents to automate first drafts of regulatory documents.
Growing drug development complexity and regulatory demands created bottlenecks in medical writing. Asphalion paired its consulting expertise with Narrativa Navigator, trained on EMA and FDA compliance requirements, to auto-draft documents from patient narratives to CSRs and TLFs. The page reports faster drafting and more consistent submissions but no figures.
Narrativa is a generative AI software company for life sciences, used by pharma sponsors and CROs to auto-draft patient safety narratives, clinical study reports and regulatory documents
This sits in the Build stage of the AI use-case lifecycle: Named examples from the foundation-model labs and platforms pharma teams use to actually construct, train and generate the model or application.
Published by Narrativa on its own site — read the original case study on narrativa.com ↗
Note: Partnership announcement; no quantified results.
Related use cases
- 01A top-3 pharma automated patient safety narrative authoring with Narrativa Navigator.
- 02Blood Cancer United automated patient safety narratives, CSRs and TLFs with Narrativa Navigator.
- 03A leading biopharma used Narrativa's Clinical Atlas to generate narratives, CSRs and TLFs in hours instead of weeks.
- 04Insud Pharma is using Narrativa to auto-generate large parts of its clinical trial regulatory documentation.
- 05OpenAI's dedicated healthcare vertical page/launch post.
- 06Frontier reasoning model built for biology, drug discovery and translational medicine; named qualified customers include Amgen, Moderna, Allen Institute, and Thermo Fisher Scientific.