40–50%
less effort per technical-file gap analysis
100%
of Annex II/GSPR requirements checked, not sampled
8 weeks
to a first agent in your validated environment
Agents across the technical file, the quality record and the post-market file — applying your SOPs and MDR/IVDR requirements to evidence you already hold, clause by clause.
What We Offer
Technical file gap check
Every Annex II and GSPR requirement mapped to the evidence that satisfies it, so the gaps surface before a notified body finds them. Nothing the agent is unsure about is closed silently.
ANNEX II · GSPR · GAP MAP
CAPA root-cause clustering
Deviations and CAPAs clustered to expose recurring causes and repeat closures across the whole quality record, not one file at a time.
DEVIATIONS · CAPA · ROOT CAUSE
Audit trail review
Scheduled audit trails reviewed at full coverage rather than by sample, with the review itself recorded as inspection evidence.
FULL COVERAGE · EVIDENCE LOG
Label and UDI consistency
Every market variant checked against the master label and applicable requirements, with each mismatch linked to the relevant compliance requirement.
LABEL CONSISTENCY | UDI VALIDATION
Post-market report assembly
PMS and PSUR content drafted from complaints, vigilance data and literature, with every figure traceable to the record behind it.
PMS · PSUR · VIGILANCE
What You Get
A gap register you can act on
Every Annex II and GSPR requirement listed against the evidence that meets it, with the clause and the owner attached.
Evidence that survives the audit
Each check leaves a log an assessor can follow, so the review effort becomes the inspection proof.
One review surface
QMS, design history file, complaints and artwork read together instead of file by file.
55–65%
less effort per monitoring and TMF cycle
100%
of filed artefacts scanned, against a 10–20% sample
Continuous
filing between milestones, not before inspection
Agents across monitoring, the trial master file, participant data, safety and submissions — applying your study rules and sponsor SOPs to records already captured, so teams move from manual execution to oversight.
What We Offer
Clinical research assistant
Site risks identified and prioritised proactively, with comprehensive pre-visit summaries and actionable recommendations that strengthen trial oversight and compliance.
RISK SIGNALS · PRE-VISIT · OVERSIGHT
Trial master file agent
Trial documents organised and filed continuously across studies, running between milestones rather than in a pre-inspection scramble.
FILING · CONTINUOUS · CROSS-STUDY
PI review agent
eCOA and participant data monitored and assembled for the principal investigator, so review and sign-off start from a prepared position.
eCOA · PARTICIPANT DATA · SIGN-OFF
Safety and pharmacovigilance agent
Case intake triaged, narratives drafted from the source records, and evidence routed to the right reviewer with the trail intact.
INTAKE · NARRATIVE · ROUTING
Regulatory and submission readiness
Submission components checked against the applicable requirements and assembled, with what is still outstanding named rather than discovered late.
COMPONENTS · CHECKS · ASSEMBLY
What You Get
A gap register you can act on
Every Annex II and GSPR requirement listed against the evidence that meets it, with the clause and the owner attached.
Evidence that survives the audit
Each check leaves a log an assessor can follow, so the review effort becomes the inspection proof.
One review surface
QMS, design history file, complaints and artwork read together instead of file by file.
35–45%
less effort assembling a submission-ready dossier
100%
audit-trail coverage, against 2–5% sampling
Days not weeks
to draft a health-authority response
Agents across the quality record, batch documentation and submission dossiers — applying your GMP procedures and target submission formats to data already sitting in your systems.
What We Offer
Annual product quality review assembly
The APQR drafted from deviations, CAPAs, complaints and stability data, with each figure linked back to the record it came from and each gap named rather than smoothed over.
DEVIATIONS · CAPA · STABILITY
Deviation investigation support
Comparable historical events retrieved and an investigation structure drafted, so the investigator starts from precedent instead of a blank form.
PRIOR EVENTS · DRAFT STRUCTURE
Submission readiness check
Dossier completeness and internal consistency tested against the target format before filing, with summary figures checked against source modules.
DOSSIER · CTD · CONSISTENCY
Batch record review
Missing entries, signature order and corrections checked ahead of QA release, with every exception pointing at the page it sits on.
ENTRIES · SIGNATURES · QA RELEASE
Data integrity and Part 11 check
Deletions, overrides and unreviewed audit trails flagged, and system configuration tested clause by clause against Part 11 and Annex 11.
AUDIT TRAILS · PART 11 · ANNEX 11
What You Get
Draft-ready APQRs
Assembled from deviations, CAPAs, complaints and stability data, with every figure traced to its record.
Investigations that start from precedent
Comparable historical events retrieved and structured before the investigator writes a line.
Release-ready batch records
Missing entries, signature order and corrections checked ahead of QA release.
50–60%
less staff time per prior-authorisation package
~60% → 85%+
first-pass-complete intake
100%
of intake packs checked for consent version
Agents across intake, coverage and appeals — applying payer policy requirements to the clinical record and preparing the package a clinician signs. We work as the technology layer behind a hub or BPO.
What We Offer
Prior authorisation preparation
The evidence a specific payer policy requires, assembled and drafted for a clinician to approve. The policy citation sits next to every element, so the reviewer checks a claim rather than rebuilds one.
POLICY EVIDENCE · CLINICIAN SIGN-OFF
Appeal letter drafting
A policy-cited appeal built from the denial reason and the clinical record, ready for the same clinician to review and send.
DENIAL REASON · POLICY CITE
Eligibility and coverage check
Coverage verified and missing documents named before the claim goes out, rather than after the denial arrives.
COVERAGE · MISSING DOCS
Documentation completeness review
Encounter notes checked against coding and payer requirements at the point of capture, while the visit is still fresh.
NOTES · CODING · PAYER RULES
Denial pattern analysis
Where and why denials cluster, for teams that want the diagnosis before committing to a fix.
DENIALS · CLUSTERS · TRENDS
What You Get
Policy-complete submissions
Each package assembled against the specific payer policy, with the citation next to every element.
Fewer avoidable denials
Coverage gaps and missing documents named before the claim goes out, not after it comes back.
Clinician time back
Drafts arrive ready for review and signature rather than for reassembly.
