Regulatory submission tracking and commitments.

• 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.

• 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.

Submission lifecycle.

1. Submission Scoped. Product, jurisdiction, type set.
2. Dossier Built. Reused components linked; commitments referenced.
3. eCTD Sequence. Granular publish with validation.
4. Gateway Delivery. Region-specific delivery.
5. Correspondence & Commitments. Agency correspondence and commitments tracked.
6. Variations on Change. Change controls emit variation tasks by market.

Submission management is where dossier assembly, commitments and agency correspondence collide. Criteria below distinguish real submission management from a shared drive.

• eCTD Lifecycle

  Are eCTD sequences, life-cycle operators and validation supported? eCTD lifecycle native with FDA/EMA/PMDA/HC profiles.

• Commitment Tracking

  Are post-approval commitments tracked with dates and owners? Commitment register with SLA and evidence link.

• Agency Correspondence

  Is correspondence linked to submissions and products? Correspondence linked to submission and product with search.

• Publishing

  Is publishing to eCTD granular and repeatable? Granular publish with checks.

• Change-Driven Variations

  Do change controls fire the variation workflow? Change controls emit variation tasks by jurisdiction.

Submission approaches.

Submission expectations.

• ICH M4 (CTD)

  CTD structure enforced in the dossier assembly.

• ICH M8 (eCTD)

  eCTD sequence and lifecycle native.

• FDA / EMA / PMDA / HC profiles

  Profile applied per submission.

• 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

• Pharmaceuticals
• Biotech
• Medical Devices
• Radiopharmaceuticals
• Document control
• Change Control Software
• Audit Trail
• 510(k)

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.