AUTOMATION · SUBMISSION INTELLIGENCESYNTHETIC DATARA LEAD · DRUG

Submission Intelligence

The master dossier compiled into each market grammar by rule — CTD, ACTD, Peru checklist, Ethiopia national permit — with a reviewer accepting every run.

Master Dossier → Market Dossier

Two distinct outputs, and conflating them is the most expensive mistake available here. The master is one signed article per product identity. The market dossier is what a regulator actually receives — one per market, registration type and packaging configuration.

MASTEROne per product identity

Molecule, strength, dosage form and manufacturer. Holds modules 2 to 5 in full, every supplier block, every version. Signed once the gaps close, and never overwritten.

IDENTITYSolufexin 0.4 mg MR · Bangkok plant

CONTENTS318 documents · modules 2 to 5 complete

VERSIONv6 — signed 14 Aug 2026

DRAWN ON BY4 live market dossiers

MARKETOne per registration

Modules 2 to 5 carried across unchanged. Module 1 rebuilt to that country’s checklist, then bookmarked and sequenced to the market template — an exact match, or the portal rejects it on upload.

VIETNAMACTD · renewal · 3 × 10 — 16 module 1 docs

VIETNAMACTD · renewal · 10 × 10 — separate registration

PHILIPPINESACTD · new · 10 × 10 — 2 rules held

NIGERIACTD · new · 3 × 10 — approved, pack pending

SCOPE NOTEMega’s stated first-phase requirement is the master dossier. The market dossier is built here as platform capability — without it the master cannot be matched to a market grammar, which is the step that makes a submission possible at all.

“Once the master dossier is ready and three markets are approved, the system should know the Philippines template is ACTD, know which section each CTD document goes to, fetch it from the master and generate the dossier. Once we give a prompt, it compiles by itself.” — Rajiv Menon, GM Regulatory Affairs

SOURCE

Master dossier (CTD)

318 documents · from NPD

Resolve template

Approved market template, current revision

Map sections

CTD module → ACTD part / national index

Fetch from master

Rule-checked, repeating rows expanded

Assemble

OCR, bookmarks, hyperlinks, gap report

HUMAN

Accept and e-sign

RA owns the outcome

Market Rules In Force

Set once when the template is created. The compiler will not substitute a master document that fails a rule.

PhilippinesMANDATORY RULE

Raw analytical data of one batch required alongside the COA. The master batch analysis document alone will not be substituted.

VietnamCONDITION SET

Zone 4B stability data required; Zone 2 packs from European suppliers do not satisfy it.

PeruNATIONAL FORMAT

Own checklist and own index. New and renewal share one template because the guideline demands the same dossier.

EthiopiaCERTIFIED ONLY

National permit annexes must be certified translations — machine drafts cannot be submitted.

Repeating Sections

A static checklist cannot hold this. Sections expand per active ingredient and per API supplier.

3.2.S DRUG SUBSTANCE · SOLUFEXIN

API 1NorvexaDMF + CEP on file

API 2KaviroDMF on file

API 3SintellDMF pending from supplier

Provastide adds its own 3.2.S set — two actives, so two drug master files, and the Solufexin block is replicated three times.

Compilation Runs

ALL ACTIVE MARKETS

MARKET

FORMAT

MAPPED

OPEN GAP

STATE

Vietnam

Provastide + Solufexin

ACTD

286 / 318

Zone 4B stability data

IN REVIEW

Philippines

Provastide + Solufexin

ACTD

301 / 318

Raw batch data + letter of access

IN REVIEW

Peru

Vitamin E Softgel 400 IU

NATIONAL

142 / 176

Checklist Rev 8 annexes pending

GAPS OPEN

Ethiopia

Omega-3 Softgel 1000 mg

NATIONAL

118 / 164

Certified annex translations

GAPS OPEN

Thailand

Calcium + D3 Softgel

ACTD

204 / 204

None

READY

Kenya

Multivitamin Softgel

CTD

187 / 212

Site GMP certificate expiring

IN REVIEW

Nigeria

Vildaglin 25 mg tablets

CTD

96 / 198

Supplier pack incomplete on intake

NEEDS REVIEW

Section Mapping · Philippines run, Solufexin 0.4 mg MR capsules

Every target row, what it drew from the master, and why anything is held. A held row cannot be cleared by substitution.

TARGET SECTION

DREW FROM

VER

RESULT

NOTE

Administrative & product information

PART I · 1.0

Master 1.0 — full set

MAPPED

Local agent details and application form generated from the market profile.

Quality overall summary

PART II · 2.3

Master 2.3

MAPPED

ACTD headings rewritten from CTD numbering; content unchanged.

Drug substance — Norvexa

PART II · S

Master 3.2.S block 1

MAPPED

DMF and CEP both on file; open part attached, closed part referenced.

Drug substance — Kaviro

PART II · S

Master 3.2.S block 2

MAPPED

Second replication of the same section structure.

Drug substance — Sintell

PART II · S

—

MISSING

DMF never received. Supplier chased three times; blocks the run.

Batch manufacturing records

PART II · P.3

Master 3.2.P.3

RULE HELD

Market requires raw batch data, not the summary. Summary cannot be substituted.

Stability data

PART II · P.8

Master 3.2.P.8 (zone 2)

RULE HELD

Zone 4B data required. Existing zone 2 study is not acceptable here.

Container closure system

PART II · P.7

Master 3.2.P.7

MAPPED

3 × 10 configuration only — the 10 × 10 pack is a separate registration.

Bioequivalence study report

PART IV · 5.3

Master 5.3

MAPPED

Comparator sourced in-region, so no additional study triggered.

Authority Submission Portals

The eCTD gateway for each market, connected once and reachable from inside the workspace. Nobody hunts for a URL, and nobody leaves the platform to find one. The platform prepares and hands off the pack — the named account signs in and submits.

ONE-TIME API SETUP

AUTHORITY

GATEWAY

CREDENTIAL HELD BY

LINK

Vietnam NRA

ACTD · electronic

National online submission portal

RA Vietnam lead

NAMED ACCOUNT

CONNECTED

Philippines NRA

ACTD · electronic

e-Portal, agent-linked account

Local agent

DELEGATED

CONNECTED

Thailand NRA

ACTD · eCTD v4

eSubmission gateway

RA Thailand domestic

NAMED ACCOUNT

CONNECTED

Peru NRA

National checklist · PDF

Mesa de partes virtual

RA international, Mumbai

NAMED ACCOUNT

CONNECTED

Ethiopia NRA

National permit · PDF

Regulatory information system

Local partner

DELEGATED

SETUP DUE

Kenya NRA

CTD · electronic

Online portal, partner-linked

Local partner

DELEGATED

SETUP DUE

HUMAN GATEThe platform never authenticates as a person. The pack is prepared, signed off and handed to the account holder, who submits on their own credential — that boundary is what keeps the audit trail attributable.

SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.