Regulatory submission software that runs the lifecycle, not just the compilation.
V5 Regulatory runs the submission lifecycle: planning, authoring, review, publishing (eCTD / non-eCTD), gateway submission, health-authority correspondence, commitment tracking and change impact — with the archive that reconstructs any historical submission on demand.
What breaks without this.
Submissions are project-based, not systemic
Every filing is a fresh spreadsheet and a shared drive — with no continuity from IND to NDA to post-approval variations.
Commitments fall through
Post-approval commitments to FDA and EMA sit in a Word doc; the due date passes; the warning letter follows.
Health-authority correspondence is scattered
Emails in Outlook, letters in a filing cabinet, meeting minutes in OneDrive — no single record of what was agreed with the agency.
Records-by-execution. Compliance, by design.
Submission planning and dossier structure
eCTD 4.0 / v3.2.2 module structure, MDR STED, DMF, 510(k) — with reusable content components across submissions and markets.
Authoring and review with SME workflow
Section-level assignment, review with tracked changes, approval gates and QC checks — with template libraries per agency.
Publishing and gateway submission
eCTD publishing with validation (FDA / EMA / Health Canada / PMDA / Swissmedic profiles), ESG / CESP / PMDA gateway submission, ACK monitoring.
Correspondence and commitment tracking
Every letter, email, meeting and teleconference logged against the product and submission; commitments extracted with owner and due date, escalated before expiry.
Change impact and lifecycle
Variation / supplement / annual report impact assessment against the approved dossier — no more guessing whether a change is Type IA or Type II.
What to look for when you're buying.
Submission management is where dossier assembly, commitments and agency correspondence collide. Criteria below distinguish real submission management from a shared drive.
eCTD lifecycle
What it tests: Are eCTD sequences, life-cycle operators and validation supported?
Why it matters: Rejection at gateway costs weeks.
V5: eCTD lifecycle native with FDA/EMA/PMDA/HC profiles.
Commitment tracking
What it tests: Are post-approval commitments tracked with dates and owners?
Why it matters: Missed commitments are agency-visible.
V5: Commitment register with SLA and evidence link.
Agency correspondence
What it tests: Is correspondence linked to submissions and products?
Why it matters: Otherwise history is unfindable at renewal.
V5: Correspondence linked to submission and product with search.
Publishing
What it tests: Is publishing to eCTD granular and repeatable?
Why it matters: Manual publishing is where errors enter.
V5: Granular publish with checks.
Change-driven variations
What it tests: Do change controls fire the variation workflow?
Why it matters: Otherwise variations lag actual change.
V5: Change controls emit variation tasks by jurisdiction.
Spreadsheet vs legacy QMS vs V5.
Submission approaches.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| eCTD lifecycle | Manual | Separate tool | Native |
| Commitment tracking | Excel | Optional | Native SLA |
| Correspondence linkage | Folder | Partial | Native linkage |
| Variation emission from change | Manual | Manual | Automatic |
The clauses, verbatim — and how V5 answers each.
Submission expectations.
Common Technical Document...
V5: CTD structure enforced in the dossier assembly.
Electronic Common Technical Document...
V5: eCTD sequence and lifecycle native.
Region-specific validation and gateway rules.
V5: Profile applied per submission.
Step by step on the floor.
Submission lifecycle.
- 1Plan
Submission scoped
Product, jurisdiction, type set.
- 2Assemble
Dossier built
Reused components linked; commitments referenced.
- 3Publish
eCTD sequence
Granular publish with validation.
- 4Submit
Gateway delivery
Region-specific delivery.
- 5Track
Correspondence & commitments
Agency correspondence and commitments tracked.
- 6Vary
Variations on change
Change controls emit variation tasks by market.
The math, with the assumptions visible.
Submission ROI is dossier speed and commitment posture.
Dossier assembly time
Reused components and validated assembly.
Missed commitments
SLA-tracked register.
Variation lag from change
Automatic emission.
Submission programs typically recover investment inside the first two major submissions.
What changed on the floor.
Setting
A pharma with 30+ markets and 12 major submissions/year.
Before
Commitments tracked in Excel; two missed in prior year.
After
Zero missed commitments in the last four quarters; variation lag from change halved.
Proof points
- eCTD published and validated inside the platform, not a bolt-on tool
- Commitments never fall off — escalation is workflow, not calendar
- Every agency interaction lives in one product-level record
- Historical submissions reconstructable in one export
Built to satisfy
- ICH M4 / M8 (CTD and eCTD)
- ICH E6(R3) (GCP submissions)
- 21 CFR 314 (NDA/ANDA), 21 CFR 312 (IND), 21 CFR 807 (510(k))
- EU MDR 2017/745 Annex II (technical documentation)
- EMA eSubmission Roadmap and validation criteria
Related on V5
Frequently asked questions
Does V5 publish eCTD or do we still need Lorenz / EXTEDO?+
V5 publishes eCTD 3.2.2 and 4.0 with FDA / EMA / Health Canada / PMDA / Swissmedic validation profiles. Sites retire their standalone publisher at go-live; enterprise MAHs can run V5 alongside for lifecycle and correspondence only.
Can V5 handle both drug and device submissions?+
Yes — drug (IND / NDA / ANDA / BLA / DMF), device (510(k) / PMA / MDR TD / IVDR TD) and combination products in one platform, with the right taxonomy applied per product.
How does V5 track post-approval commitments across markets?+
Commitments are extracted at approval, tagged per market and per commitment type, with owner, due date and evidence-of-completion workflow. Cross-market status is a live dashboard, not a quarterly spreadsheet.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.