WALKTHROUGH · TEMPORARY PAGESYNTHETIC DATARA LEAD · DRUG
How The System Works
The whole chain in one read: who acts, where clinAImate acts beside them, what lands in the record, and the human gate that has to clear before anything moves.
TEMPORARY
Walkthrough page — not part of the product surface
One page that reads the whole chain in order: what a person does at each step, what clinAImate does beside them, what gets written to the record, and where a human has to sign before anything moves. Remove this page once the flow is agreed.
Your team actsaiclinAImate actsWritten to the recordHuman gate — nothing passes without it
The chain, end to end
The four industry-standard stages — pre-market, R&D, market authorisation, post-market — carrying Mega's own NPIE / NPD / NPR / NPL codes so the team recognises its own records. Market authorisation is where the AI carries the most weight.
NPIEPre-Market
Mega calls this Idea Evaluation
ENTERS
Business Development raises an idea with target markets and a revenue forecast.
AI ACTS
Drafts the regulatory feedback per market from template rules and past filings — feasibility, category, dossier type, BE need and the cost lines that belong in the business case.
LEAVES
Seven cross-functional inputs on one record; BD opens or holds the gate.
NPDResearch & Development
Mega calls this Development
ENTERS
In-house development output, or an outsourced supplier pack of scans and native files.
AI ACTS
Reads the pack on intake, builds the master dossier, and names what is missing against every target market at once rather than one at a time.
LEAVES
One versioned master dossier per molecule, strength, form and manufacturer.
NPRMarket Authorisation
Mega calls this Registration
ENTERS
One project per market, registration type and packaging configuration.
AI ACTS
Compiles the master into the market grammar, audits it against the rule set and deficiency history, predicts the questions and drafts the answers.
LEAVES
Approval on file and a consolidated approved dossier on demand.
NPLPost-Market
Mega calls this Launch
ENTERS
Approval plus certified artwork and pack inserts.
AI ACTS
Watches expiry dates and variation dependencies so a launch is never held up by a change nobody tracked.
LEAVES
Purchase order to the manufacturing site, produced to the approved version.
The chain, lane by lane
Ten steps from a supplier pack landing to an approval on file. Two things worth reading closely: the master dossier is produced after the gaps close and the go decision is made, not at the start; and the market dossier is a separate output from the master, because module 1 is the country. Every row reads in the same order — your team, clinAImate, the record it writes, then the gate.
01Intake
PRE-MARKETR&D · DOCUMENTS
YOUR TEAM
Point the platform at the shared drive or the supplier pack. No renaming, no re-foldering.
CLINAIMATE
OCR, bookmarks and hyperlinks every scan, classifies each file to a dossier section, and scores its own confidence per document. Pages it could not read are flagged, never inferred.
SYSTEM OF RECORD
Documents land with a section, a version, a source and a confidence score.
THRESHOLDBelow 90 percent confidence the document is held for a human read rather than passed downstream. A thousand-page report with one unreadable annexe says so at intake, not at submission.
02Compilation
PRE-MARKETR&D · COMPILE
YOUR TEAM
Review only what could not be mapped, and accept the draft structure.
CLINAIMATE
Reads everything that landed, resolves duplicates and superseded versions, and assembles one draft index per product identity — every row carrying its source, version and confidence.
SYSTEM OF RECORD
Draft index, with provenance behind each row.
THRESHOLDThe run cannot be accepted while any row sits below the confidence threshold. Acceptance is a person, not a score.
03Market rules
PRE-MARKETMARKET · TEMPLATE
YOUR TEAM
Choose the target market, registration type and packaging configuration.
CLINAIMATE
Resolves the grammar — CTD or ACTD — and turns the released market template into a rule set. Modules 2 to 5 are common; module 1 is written to the country and is where almost all the variance lives.
SYSTEM OF RECORD
Rule set attached to the project: required sections, repeats, format, language.
GATEOnly a template revision released by its approver can be used in a live project. A wrong module 1 template is an instant portal rejection, before a reviewer reads any science.
04Gap analysis
PRE-MARKETMARKET · AUDIT
YOUR TEAM
Own the gaps: chase the supplier, commission the study, request the letter.
CLINAIMATE
Runs the draft against the rule set and the deficiency history, then prices and dates each gap — study cost, testing, legalisation, translation, certificates.
SYSTEM OF RECORD
Gap list with owner, cost to close, added duration and a needs-review flag.
GATEA gap is a pre-market finding. Nothing here is a deficiency yet — that word only applies after a submission exists.
05Go / No-Go
PRE-MARKETMARKET · DECISION
YOUR TEAM
Decide, per market, whether the opportunity justifies closing the gaps.
CLINAIMATE
Presents the position: gaps open, cost, added time, and the comparable markets already carrying the same requirement.
SYSTEM OF RECORD
Decision recorded against the market with its rationale and the person who made it.
HUMAN GATEA no-go closes that market here, with the reason on the record. Only a go proceeds into the market stage.
06Master dossier
MARKETMARKET · MASTER
YOUR TEAM
Confirm product identity and sign the master index.
CLINAIMATE
Finalises the master once the gaps are closed and every rule is satisfied, and checks it against current industry standards rather than the ones that applied when the pack was assembled.
SYSTEM OF RECORD
One signed master per identity, every document versioned and citable.
GATERA lead signs the master. A superseded standard cannot survive into a signed master.
07Market dossier
MARKETMARKET · COMPILE
YOUR TEAM
Review the market-specific module 1 and accept the compiled output.
CLINAIMATE
Compiles the signed master into the market grammar: modules 2 to 5 carried across, module 1 built to that country's checklist, supplier blocks replicated, bookmarks and hyperlinks generated to the market convention.
SYSTEM OF RECORD
One market dossier per registration — per market, per registration type, per packaging configuration.
GATEThe output has to match the market template exactly. A reviewer accepts the run before it leaves the platform.
08Submission
MARKETMARKET · PORTAL
YOUR TEAM
Submit on your own credential, through the authority gateway.
CLINAIMATE
Prepares and hands off the pack, then records what was filed, when, and against which versions.
SYSTEM OF RECORD
Submission event pinned to the document versions it contained.
HUMAN GATEThe platform never authenticates as a person and never transmits. That boundary is what keeps the audit trail attributable.
09Deficiency & queries
POST-MARKETPOST-MARKET · HAQ
YOUR TEAM
Answer the authority in your own words, and sign.
CLINAIMATE
Locates the section, the version that answers it and the reason it was queried before, then drafts a cited response and pins it to the round.
SYSTEM OF RECORD
Query round, item, answering version, reason for change.
HUMAN GATENo response leaves without RA sign-off. The pattern then feeds the next audit, so the same deficiency is pre-empted rather than re-answered.
10Approval & lifecycle
POST-MARKETPOST-MARKET · NPL
YOUR TEAM
Accept the approval, then raise variations and renewals as the product changes.
CLINAIMATE
Generates the consolidated approved dossier, watches authority and standards movement, and assesses each incoming change — a strength change from 100 mg to 120 mg is a variation in some markets and a new registration in others.
SYSTEM OF RECORD
Approved versions pinned; renewal clock and variation chain started.
GATEThe consolidated pack is released by the project owner, not automatically.
aiWhere the AI acts
Eight jobs, each with a defined input, a defined output and the gate that follows it.
Document intake
INSigned and legalised scans, native files, supplier packs.
OUTSearchable, bookmarked, hyperlinked documents classified to sections.
GATEUnreadable pages are flagged, never inferred.
Rule extraction
INA released market template revision.
OUTMachine-readable rule set: sections, repeats, format, language.
GATEApprover releases the revision before it is usable.
Compilation mapping
INMaster dossier plus the market rule set.
OUTTarget index with per-row mapped / missing / rule-held.
GATEHeld rules keep the run open.
Gap analysis
INThe run, market conditions, past deficiencies.
OUTRanked gap list with owners and predicted questions.
GATEFiling with a gap is a human call.
Query drafting
INAuthority question and the document versions in scope.
OUTCited draft response with the answering version pinned.
GATERA signs before anything is sent.
Regulatory monitoring
INAuthority publications and checklist reissues.
OUTTemplate diff plus the live projects it affects.
GATENew revision needs its approver.
Language drafting
INArtwork, pack inserts, annexes.
OUTDraft local-language version aligned to the approved text.
GATEA qualified expert certifies before submission.
Grounded answers
INA question in plain words, anywhere in the workspace.
OUTAnswer with the documents it came from, cited.
GATERefuses when the only source is a draft.
Where it stops
The refusals are the design. A regulatory system earns trust by what it declines to do.
×It never submitsNothing reaches an authority from the platform. Submission stays a human act on a human account.
×It never files a machine translationLocal-language artefacts are drafted by machine and certified by a qualified expert. An uncertified draft cannot be attached to a submission.
×It never answers without a citationIf the graph holds no approved source, the answer is a refusal and a request — not a plausible paragraph.
×It never uses an unreleased templateA revision sits inert until its approver releases it, however obviously correct the change looks.
×It never supersedes a versionv3 replaces v2 only after the signature. Until then both exist and the older one is what gets cited.
×It never invents a documentA missing study report stays missing and open. The system names the owner and the wait, and holds the run.
The query loop
The one cycle that repeats until a file closes — and the one that teaches the system.
01Authority raises a question against a submitted section.AUTHORITY
02AI locates the section, the version that answers it and the reason it was queried before.AI
03RA edits the draft, adds what only a person knows, and signs.HUMAN GATE
04Response filed; the answering version is pinned to the round.RECORD
05Deficiency history learns the pattern, so the next dossier pre-empts it at audit.AI
See the answer path yourself
Ask in plain words and watch the four beats: the retrieval trace naming what it read, the grounded answer, the cited documents, and a refusal when the only source is a draft. Nothing in the panel is generated from memory.
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.