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
Oversight, not execution
Monitoring, filing and assembly run continuously, so study teams review exceptions instead of working the queue.
Risk surfaced early
Site signals prioritised and summarised before the visit, while there is still time to act on them.
Evidence that holds up
Every narrative, filing and submission component traced to its source record and reviewer.
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 effort per SKU dossier
100%
of claims traced to a substantiation source
100%
of ingredient entries screened across every market
Agents across safety dossiers, the claims matrix and market registrations — applying MoCRA, DSHEA and per-market ingredient rules to your formulation, label and study data, SKU by SKU.
What We Offer
Safety substantiation file assembly
The MoCRA product information file and supplement safety dossier built from what you already hold, with exactly which evidence is missing named per SKU rather than left for a reviewer to discover.
MoCRA · PIF · DSHEA · SAFETY EVIDENCE
Ingredient restriction screening
INCI entries and supplement ingredients screened across every target market, with prohibited entries and concentration breaches flagged against the limit that applies there.
INCI · LIMITS · MARKETS
Claims substantiation check
Each marketing and structure-function claim traced to the study behind it, with wording the evidence cannot carry flagged before artwork is locked.
CLAIMS · STUDIES · WORDING
Label and allergen verification
Ingredient lists, allergens, Supplement Facts panels and mandatory statements checked against the formula and the rules of each market you sell in.
ALLERGENS · SUPPLEMENT FACTS
Registration and listing maintenance
Facility registrations and product listings tracked against renewal dates and reformulation triggers, so nothing lapses quietly.
RENEWALS · REFORMULATION
What You Get
SKU-level safety files
MoCRA product information files and supplement dossiers built from what you already hold, with gaps named.
Claims you can defend
Every claim traced to the study behind it before artwork locks
Coverage across every market
Ingredient screening and label checks run per market, not per launch.
