PRE-MARKET · SOURCE SYSTEMSSYNTHETIC DATARA LEAD · DRUG
Source Systems & Input / Output Map
Where each dossier section gets its data, which system of record holds it, and which artefacts the platform produces rather than receives.
OPEN WITH CUSTOMER
Everything shared so far is an output
The folders on the shared drive are the finished dossier — what gets pointed at a regulator gateway. They are not what the platform needs to read. To classify at intake and drive a rule engine we need the inputs: product and labelling master data, manufacturing and analytical records, study outputs, and the correspondence history. This page is the register of where each of those lives, and it is deliberately honest about what has not been confirmed yet.
System-of-Record Checklist
One row per candidate source system. A mature manufacturer holds this data somewhere even without the named platform — the question is which system, and whether we can get a data dictionary and sample extract.
SYSTEM
WHAT WE NEED FROM IT
FEEDS
STATE
RIM
Regulatory information management
Registration inventory, licence numbers, expiry dates, authority correspondence history.
M1 · LIFECYCLE
NOT CONFIRMED
EDMS / DMS
Document management system
Controlled documents with version, effective date and approval state — the spine of intake.
ALL MODULES
SHAREPOINT
LIMS
Laboratory information management
Specifications, methods, batch analytical results and the raw data behind each certificate.
M3 · QUALITY
NOT CONFIRMED
ELN
Electronic lab notebook
Development history and method development records supporting the quality narrative.
M3 · M4
NOT CONFIRMED
MES
Manufacturing execution system
Batch manufacturing records, process validation, in-process controls, site and line data.
M3 · P.3
IN-HOUSE UI
SCE
Statistical computing environment
Study tables, listings and figures generated from the analysis datasets.
M5 · CLINICAL
UNLIKELY
ERP
Enterprise resource planning
Semi-finished goods codes, packaging configurations, site and supply relationships.
M1 · NPL
IN-HOUSE
PV
Pharmacovigilance
Safety reporting obligations post-approval. Approved generics, so no trial safety database expected.
POST-MARKET
OUT OF SCOPE
ASKFor each confirmed system: a data dictionary and a sample extract. Where a system does not exist, we need the walkthrough of where that data actually sits today — and until then the platform runs that section on synthetic data rather than assuming a shape.
Section Input / Output Map
Read across: the dossier section, what data fills it, where that data comes from, and whether the artefact is something the platform produces or something a person supplies. Module 1 is mostly supplied and market-specific; modules 2 to 5 are produced and common across markets.
SECTION
DATA REQUIRED
SOURCE
EXPORT
I / O
M1 · 1.2
Application form
Product identity, applicant, local agent, packaging configuration.
RIM / ERP
DOCX
SUPPLIED
M1 · 1.3
Product information
Approved labelling text, pack insert, artwork proofs.
EDMS
PDF
BOTH
M1 · 1.4
Certificates
CPP, GMP certificate, letter of access, apostille pages.
RIM / AUTHORITY
PDF
SUPPLIED
M2 · 2.3
Quality overall summary
Rolled-up summary of every module 3 section.
DERIVED
DOCX
PRODUCED
M2 · 2.4
Non-clinical overview
Pharmacology and toxicology summary plus supporting literature.
ELN / LIT
PDF
PRODUCED
M3 · 3.2.S
Drug substance
DMF or CEP per approved API supplier — replicates per source.
SUPPLIER
PDF
SUPPLIED
M3 · 3.2.P.3
Batch manufacturing
Batch records, process validation, in-process control results.
MES
PDF
PRODUCED
M3 · 3.2.P.5
Analytical control
Specifications, method validation, batch analyses and raw chromatograms.
LIMS
PDF + XLSX
PRODUCED
M3 · 3.2.P.8
Stability
Long-term and accelerated data under the zone the market requires.
LIMS
XLSX + PDF
PRODUCED
M5 · 5.3
Clinical study reports
Bioequivalence report with tables, listings and figures.
SCE / CRO
PDF
BOTH
Dossier Grammar
Two formats carry almost everything. Modules 2 to 5 are common; module 1 is the country.
CTDCommon Technical Document
Five modules. Modules 2 to 5 are identical across every market that accepts CTD; module 1 is written to the country. The electronic form is eCTD.
Nigeria · Vietnam · Peru · Kenya · Ethiopia · EU · US
ACTDASEAN Common Technical Dossier
The ASEAN association standard, used where a national agency defers to the regional framework. Four parts rather than five modules. Standardised — there is no per-country sub-ruling inside it, which makes it the cheaper grammar to support.
Myanmar · Philippines · Thailand · Cambodia · Laos
Module 1 Is The Variable
The same product, four markets, four different module 1 sets. Getting the template wrong is an instant portal rejection, before any reviewer reads the science.
NG-M1NigeriaCTD module 1. National permit annexes plus local agent appointment.14 docs
MM-P1MyanmarACTD Part I. Defers to the ASEAN framework, so no national sub-ruling.11 docs
VN-P1VietnamACTD Part I with a certified Vietnamese artwork and insert set.16 docs
PE-M1PeruNational checklist with a fixed annexe order — reissued mid-registration in 2026.19 docs
ET-M1EthiopiaNational permit format. GMP certificate scope wording tightened this year.13 docs
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.