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, Annex I §23 and QMSR 820.45, with each mismatch shown next to the rule it breaks.
ANNEX I §23 · QMSR 820.45
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 TMF quality review
100%
of filed artefacts scanned, against a 10–20% sample
Validity
expired and undelegated caught, not just missing
Agents across the trial master file, the protocol and site records — applying your study rules and sponsor SOPs to documents already filed, at full coverage rather than by sample.
What We Offer
TMF inspection readiness
Missing, expired and superseded records scored site by site across the full trial master file — not a 10% sample — with cross-document validity checked, not just presence.
TMF · SITE SCORING · VALIDITY
Protocol burden analysis
Every procedure mapped to an endpoint, with the ones supporting none flagged while the protocol can still be changed.
PROCEDURES · ENDPOINTS
Site feasibility response
Feasibility questionnaires pre-filled from prior responses and current site records, so coordinators review rather than retype.
QUESTIONNAIRES · SITE RECORDS
Deviation pattern monitor
Clusters by site or procedure flagged while they are still a trend, before they harden into an inspection finding.
CLUSTERS · SITES · SIGNALS
Startup document tracker
Approvals, delegation logs, training and contracts tracked against activation milestones, with what is blocking each site named.
APPROVALS · DELEGATION · TRAINING
What You Get
The whole TMF, not a sample
Every filed artefact scored site by site, so readiness is a number rather than a hunch.
Findings before the inspector
Expired, superseded and undelegated records surfaced while there is still time to fix them.
Faster study startup
Feasibility responses pre-filled and startup documents tracked against activation milestones.
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.
