Regulatory teams handle growing volumes of guidance, dossiers, safety data and tender documents. AI-enabled tools can help them work faster, but in a regulated industry speed must never replace accountability.
Where AI adds value
Regulatory intelligence: tracking guideline changes across multiple authorities.
Dossier quality checks: finding missing documents, inconsistencies and expired certificates.
Safety case intake: supporting triage and data extraction for ICSRs.
Literature screening: prioritising publications for safety review.
Tender analysis: matching tender requirements to product data.
Where humans must decide
Interpreting regulatory requirements and choosing a pathway.
Medical assessment of safety cases and signals.
Final approval of submissions, labelling and promotional claims.
Any decision with legal or patient-safety consequences.
Principles for responsible use
Source grounding: every output traceable to an official source.
Audit trails: records of what was generated, reviewed and approved.
Data protection: confidential and patient data kept within controlled environments.
Validation: tools tested for their intended use before being relied on.
Human sign-off: named reviewers accountable for consequential decisions.
The HERMS approach
HERMS develops its intelligence ecosystem around one principle: technology supports experts and experts make the decisions. Our platforms connect regulatory requirements, evidence and governance workflows with full traceability.
Explore how HERMS Intelligence can support your regulatory and safety teams. Contact HERMS →