Yseop Augmented Analyst: Regulatory Writing Automation
Yseop helps pharmaceutical and life sciences companies automate complex regulatory writing. It is designed for organizations that need to generate compliant documents, such as clinical study reports, while maintaining traceability.
At a glance
- Category
- Legal
- Best for
- Enterprise pharmaceutical companies, Life sciences organizations, Regulatory writing teams, Medical writers in regulated industries
- Pricing
- Yseop uses a SaaS model with annual licenses and setup costs based on the number of users. A free trial is available.
- Key use cases
- Clinical Study Report (CSR) Generation, Patient Narrative Drafting, CMC Submission Support, Preclinical Pharmacokinetics Reporting, Summary Clinical Safety Reports
- Integrations
- Tableau, Qlik, Power BI, Microsoft Word
- Official website
- www.yseop.com
Yseop is an enterprise platform that uses Natural Language Generation (NLG) and a composite AI strategy to automate the creation of regulatory and medical documents. It is designed for the life sciences and pharmaceutical industries to support the production of reports across the CTD pyramid.
The software is built for enterprise-level deployment, assisting regulatory teams and medical writers in converting structured data into narratives. By utilizing deterministic RAG and pre-trained models, the platform is designed to produce drafts that align with regulatory requirements.
Buyers should note that the platform is intended to produce first drafts for human medical writers to finalize based on specific style and writing preferences.
Companies typically implement the software through a phased process involving requirement preparation, configuration of automation packs, and validation before production deployment.
Key Features
Converts structured data into written narratives to support the creation of medical and regulatory reports.
Uses retrieval logic defined during setup to ensure outputs are based on validated and traceable content sources.
Provides pre-packaged components and configurations specific to particular document types or use cases.
Combines Symbolic AI and Large Language Models (LLMs) to balance precision with flexibility.
Supports report configuration without requiring deep technical programming knowledge.
Allows medical writers and business users to generate documents within Microsoft Word.
Use Cases
Automating core elements of specialist medical reports for clinical trials.
Converting clinical data into patient narratives for regulatory submissions.
Supporting the drafting of Quality Overall Summary (QOS) documents for Chemistry, Manufacturing, and Controls submissions.
Automating the generation of reports based on preclinical study data.
Creating summaries of clinical safety data for health authorities.
Best For
Integrations
Pricing
Yseop uses a SaaS model with annual licenses and setup costs based on the number of users. A free trial is available.
FAQ
Yseop provides automation packs for clinical study reports, patient narratives, summary clinical safety reports, and preclinical pharmacokinetics reports.
The platform is designed for enterprise-level deployment and is primarily targeted at large pharmaceutical companies and regulated businesses.
It uses a deterministic form of RAG and a two-level quality framework to ensure outputs are based on validated, traceable sources.
Yseop includes a no-code Studio that allows users to configure reports without advanced technical knowledge.
Source category: Legal
Source subcategory: Document Automation
