The submission is hand-reconciled
The bridge from a final interpretation to a regulatory argument is, in most orgs, invisible by default. RA spends weeks reconciling a narrative against the raw evidence that R&D and the CROs produced.
Solution · Regulatory AffairsDossier · Submission · Inspection
Submissions that assemble themselves from the evidence.
MolTrace turns structured scientific evidence into CTD dossier sections, multi-jurisdiction packages, and ledger entries designed to be inspection-oriented. The regulatory work becomes the output of the science — not a parallel document reconciled by hand in week eleven.
Why regulatory affairs
Four things that make submissions hard.
RA sits between the science and the agency. The job is reconciliation, currency, responsiveness, and integrity — usually against a deadline, and usually with the evidence scattered across teams and tools.
The guidance keeps moving
ICH Q2(R2), the FDA's January 2025 AI framework, the EMA reflection paper, nitrosamine expectations, and pharmacopoeia versions all shift — often at once. Keeping every affected item current is a job in itself.
Queries arrive with a clock
A health-authority deficiency letter needs an evidence-backed answer fast. Reassembling the trail for one claim — across files, emails, and people — is exactly the work that eats the response window.
You own data integrity
When an inspector arrives, RA owns the ALCOA+ story for the whole organization. 'We can reconstruct it' is not the same as 'it's queryable right now' — and only one of those survives the audit.
Across the submission lifecycle
From evidence intake to lifecycle maintenance.
The same evidence object that R&D and your CRO partners produced flows through classification, authoring, and packaging — and stays inspection-oriented for the life of the product.
The lifecycle, at a glance
Intake ──► Assess ──► Author ──► Package ──► Maintain
│ │ │ │ │
▼ ▼ ▼ ▼ ▼
cited ICH + CTD draft FDA · EMA query response
evidence risk + per claim · PMDA + surveillance
(from R&D FDA Stage (3.2.S/P) (one base) + ALCOA+ ledger
/ CRO) gates (inspection-oriented)INTAKE
Evidence intake
- Findings arrive from R&D and CRO partners as structured evidence
- Every claim already carries its trail back to the raw spectrum
- No re-keying numbers out of PDFs into a submission spreadsheet
ASSESS
Classification & assessment
- Findings mapped to ICH Q3A/Q3B/Q3C/Q3D and M7 frameworks
- Risk-based credibility + FDA Stage 1-4 oversight gates evaluated
- Items needing human review surface with the exact gate that fired
AUTHOR
Dossier authoring
- CTD section drafts composed from the underlying evidence
- Module 3.2.S.3.2, 3.2.S.4, 3.2.P.5 + AI/ML model documentation
- Every numerical claim hyperlinked to its source — no orphan numbers
PACKAGE
Multi-jurisdiction packaging
- Reuse one evidence base across FDA, EMA, PMDA, and Health Canada
- Regional templates + dossier-section mapping kept aligned to CTD
- Jurisdiction-specific content gated until the framework is verified
MAINTAIN
Query response & lifecycle
- Answer a health-authority query by retrieving the cited evidence chain
- Surveillance watches guidance sources and routes changes to your items
- ALCOA+ ledger designed to keep the whole submission inspection-oriented over its life
Workflows we light up
Six regulatory workflows, with their inputs and outputs.
Each is a typed pipeline in the product. Inputs arrive as structured evidence from the science; outputs are dossier-ready artefacts, every one cited and ledger-backed.
CTD dossier-section drafting
Draft Module 3 sections — 3.2.S.3.2 Impurities, 3.2.S.4 Control of Drug Substance, 3.2.P.5 Control of Drug Product — directly from the evidence, each claim cited to source.
Inputs
Structured evidence · framework refs
Outputs
CTD drafts · citation chain · open items
Impurity & nitrosamine packaging
Assemble the impurity argument: Q3A/Q3B organic, Q3C residual solvent, Q3D elemental, and M7 mutagenic + nitrosamine risk, each with acceptance windows and the data behind them.
Inputs
Classified findings · pharmacopoeia priors
Outputs
Impurity dossier · risk tier · recommendations
AI / ML model documentation
Produce the FDA January-2025 model-card package: training-data lineage, performance bounds, validation corpus, intended use, and known limitations — Stage 1-4 ready.
Inputs
Model artefacts · validation runs · changelogs
Outputs
Model documentation · Stage mapping · audit trail
Multi-jurisdiction management
Run one evidence base into multiple regional submissions. Shared content stays in sync; jurisdiction-specific sections are gated until the corresponding framework content is verified.
Inputs
Core dossier · regional templates
Outputs
Per-jurisdiction package · alignment report
Health-authority query response
Answer a deficiency letter by pulling the exact citation chain for the claim in question — spectrum, peak, reference window, reviewer — instead of reconstructing it from scratch.
Inputs
Query · claim reference
Outputs
Evidence chain · drafted response · ledger entry
Surveillance & change impact
Watch ICH, FDA, EMA, and pharmacopoeia sources for version changes, and auto-route the impact to the affected dossiers, rules, and action items with an ETA.
Inputs
Source feeds · pharmacopoeia versions
Outputs
Change-impact report · routed items · ETA
How the provenance works
The numbers behind a defensible submission.
The structural figures below — nine ALCOA+ fields, 40 evidence layers, bit-identical replay — are implemented in the data model itself, so provenance is built in rather than bolted on.
9
ALCOA+ fields per event
Attributable · Legible · Contemporaneous · Original · Accurate · Complete · Consistent · Enduring · Available — populated on every audit event and designed to be queryable at inspection.
40
Evidence layers per claim
Every regulatory claim rests on a typed, additive evidence stack — so a citation chain goes all the way down to the spectrum it came from.
Bit-identical
Recipe-hash replay
Designed to re-derive any processed result or report from any prior date with bit-identical output — aligned with the reproducibility ICH Q2(R2) emphasizes.
Automatic
Solvent auto-detect
Residual-solvent peaks identified automatically and routed straight into ICH Q3C classification — the impurity argument starts itself.
The honest comparison
What changes for a submission team.
Most RA teams run on documents, spreadsheets, and email threads that get reconciled under deadline. Here's what flips when the evidence — and its provenance — flows into the dossier directly.
| Dimension | Today | With MolTrace |
|---|---|---|
| Assembling a CTD section | today Hand-written narrative; numbers re-keyed from R&D and CRO reports | with MolTrace Draft composed from the evidence, each claim hyperlinked to its source |
| Reconciling narrative vs raw evidence | today Weeks of cross-referencing in week 11, often by a single reviewer | with MolTrace The dossier is a by-product of the science — the reconciliation never happens |
| Responding to a health-authority query | today Reassemble the trail for one claim from files, emails, and memory | with MolTrace Pull the citation chain for that exact claim in one query |
| Staying current with guidance | today Manual scan of new guidance; spot-check which dossiers are affected | with MolTrace Surveillance routes each change to the affected items with an ETA |
| Proving data integrity at inspection | today Reconstruct an audit trail from version history and interviews | with MolTrace One ALCOA+ ledger query — nine fields per event, designed to replay on demand |
| Reusing a submission across jurisdictions | today Re-derive each regional package by hand; content drifts apart | with MolTrace One evidence base; shared content stays in sync, regional gated until verified |
One worked example
A finding, from evidence to inspection answer.
A single residual-solvent finding followed from R&D into a multi-jurisdiction dossier — and answered cleanly when a reviewer asks about it years later.
Evidence arrives
A residual-solvent finding comes from R&D as a structured evidence object — acetic acid at 2.10 ppm, 93% confidence, already cited back to the raw FID and the HRMS that corroborated it.
It classifies itself
Regentry maps it to ICH Q3C Class 3 (no action below 5000 ppm) and slots it into dossier section 3.2.S.3.2 with the reference shift, observed shift, and delta cited.
The section drafts
The CTD draft is composed from the evidence and packaged for FDA and EMA from the same base — shared content in sync, regional content gated until the framework is verified.
An inspector asks
Months later a reviewer questions the impurity claim. One ALCOA+ ledger query returns the full chain — FID hash, recipe, classification, signoff — and replays bit-identical.
Built for inspection
Data integrity designed to stand up to inspection.
Every control below is implemented in production code — designed against ICH Q2(R2) ALCOA+, the FDA's January 2025 AI framework, the EMA reflection paper, and 21 CFR Part 11 from day one. Designed to support these frameworks, not as an afterthought — within the data model itself.
ALCOA+ audit ledger
Every event carries all nine ALCOA+ fields, designed to be queried directly at inspection rather than reconstructed from emails and version history.
Designed to support 21 CFR Part 11
Designed to support 21 CFR Part 11 electronic-records and electronic-signature requirements within the audit-event model.
Human signoff gate
Submission artefacts move through a human-signoff gate requiring explicit qualified-human attribution — designed to support the FDA Stage 4 oversight expectation.
Recipe-hash provenance
Every processing run links a recipe hash to the unchanged raw archive, so any claim in the dossier is designed to replay bit-identical years later.
Immutable raw vault
The original evidence behind every regulatory claim is SHA-256 hashed and designed not to be overwritten — provenance intended to survive the product lifecycle.
Tenant isolation & residency
Per-tenant isolation, GDPR-aligned data residency, and controls designed to support SOC 2 Type II underpin the whole submission record.
Bring your hardest submission section.
Pick a CTD section that's currently a 40-hour reconciliation, or a query you're still chasing evidence for. We'll show how MolTrace would carry it — cited and inspection-oriented — end to end.