REGULATORY AFFAIRS
Regulatory teams don’t struggle with rules. They struggle with proving, after the fact, that the right rule was applied by the right person.
Complexity by product
Oncology: Progression vs. toxicity needs clinical judgment; automation without review gates creates false signals or missed events.
Cell & gene therapy: Batch-of-one and chain-of-identity need immutable identity evidence that generic trial platforms lack.
Rare diseases: Standard disproportionality analysis can mask signals from co-administered products.
Global brands: Regional clocks and algorithms fragment one brand’s safety record across markets.
Combination products: Drug and device rules overlap, so one event can trigger different reporting obligations.
Medical & brand content: Safety review must happen before HCP-facing answers go out, not after an enforcement event.
Sponsors and CROs
Fencing: Rotating reviewers and cross-sponsor teams share access paths, risking cross-contamination between studies.
Allowed to act: AI tools run ahead of human sign-off on high-consequence calls, with no consistent gate.
Audit archaeology: When a health authority or sponsor asks “prove this decision,” evidence is rebuilt from disconnected logs.
Coexistence: New tools are pitched as rip-and-replace for safety and RIM systems nobody will migrate away from.
Jurisdiction: One case moves through three regions on three clocks, with no single pinned ruleset.
1. Rule
What applied
2. Source
The evidence
3. Human
Who signed
4. Replay
Any time after
Rules, regulations, citations and SOPs are encoded across 19 jurisdictions. AI agents move at machine speed; your regulatory experts stay accountable where it legally matters. TFives works beside your existing safety, RIM and quality systems. It is never a replacement.
Governed AI for regulatory work
Context of use, access control, review checkpoints and evidence for AI-assisted drafting and documents.
Regulatory intelligence
Pharmacovigilance and safety review
Gates before disposition, with human sign-off on high-consequence calls.
Sponsor and CRO fencing
Keep studies, sponsors and reviewers separated, with proof.
Audit-ready in one export
Answer “prove this decision” from a single case record instead of rebuilding it.
RegIQX carries evidence from supplier quality, batch records and CAPA into submission checks on the same rule library, so regulatory operations spends less time on late-cycle reconciliation.
Explore RegIQX →
“A few years ahead.”
Head of Regulatory Affairs, emerging biotech
What is regulatory affairs software?
Software that helps pharmaceutical, biotech and CRO teams manage submissions, regulatory intelligence and health authority compliance. TFives focuses on governing and proving AI-assisted regulatory work.
Does TFives replace our RIM or safety system?
No. TFives sits beside your existing systems as the system of proof, connecting each decision to its rule, source and human sign-off.
Can we use AI in regulatory affairs and pharmacovigilance?
Yes, with controls. TFives adds context of use, review gates and evidence capture so AI-assisted work stays defensible to health authorities and sponsors.
Does TFives work for CROs?
Yes. TFives supports cross-sponsor fencing, rotating review teams and sponsor audit requests with one record per case.
Which TFives product connects manufacturing evidence to submissions?
RegIQX connects supplier quality, batch records and CAPA to submission checks on one shared rule library.
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