OPERATIONS · MY DAYSYNTHETIC DATARA LEAD · DRUG
Dossier Control Tower
Every registration in flight across Southeast Asia, Africa, CIS and LATAM — and the manual load it costs today.
ai
clinAImate brief · grounded in 9 ideas, 24 registration projects, 61 templates
Two ASEAN runs are held by the same missing Zone 4B stability set, and the Vietnam chromatogram query has been open with the supplier for eleven days. The Peru checklist moved to Rev 8 — that template cannot be used in a live project until Nita Deshpande approves it.
REGISTRATIONS IN FLIGHT
24
projects
9 ideas across 13 markets
AUTO-MAPPED
87
% avg
Master CTD → target grammar
OPEN GAPS
7
items
3 waiting on suppliers
LANGUAGE QUEUE
11
artefacts
6 languages, certification pending
Pre-Market to Post-Market
The four industry-standard stages, keyed to Mega's own NPIE → NPD → NPR → NPL record codes so nothing in the 2015 system has to be renamed. Registration is where the manual load sits.
STAGE GATE OWNER · BUSINESS DEVELOPMENT
NPIE
Pre-Market
Idea Evaluation in Mega's wording. BD raises the idea with market forecast; every department returns feedback, budget and timeline.
STAGE GATE · BD
NPD
Research & Development
In-house R&D or an outsourced pack. Legal, brand name, artwork, COPP, master dossier.
6 ACTIVE
NPR
Market Authorisation
Registration in Mega's wording. Dossier compilation, market acceptance, submission, approval — one project per market and packaging.
24 PROJECTS · AI ASSISTED
NPL
Post-Market
Launch in Mega's wording. Market raises the launch, supply chain issues the PO to the supplier.
3 THIS QUARTER
Submission Format Mix
One master dossier, three target grammars. Contents are identical; only the index and formatting change.
CTDAfrica, CIS, LATAM and most partner markets52%
ACTDVietnam, Philippines, Thailand, Indonesia, Malaysia31%
NationalPeru checklist, Ethiopia national permit17%
Where The Team Time Goes
14 in Mumbai, 10 on international markets in Thailand, 5 domestic, one to three per country — 50+ in all. Thirteen of them compile dossiers.
Dossier compilation and reformatting3 managers + 10 staff
Version chasing across query rounds7 people
OCR, bookmarking and hyperlinking4 people
Supplier follow-up on gaps3 people
Needs A Human Today
SORTED BY WAITING TIME
HAQMissing chromatograms — round 2 responseRajiv Menon11 d waiting
GAPZone 4B stability data absent from supplier packSupplier — countersign8 d waiting
RUNVietnam ACTD run — accept 286 mapped documentsRA Ops, Mumbai2 d in review
LABELThai carton and insert — expert certificationCertified reviewer, Bangkok1 d in review
TPLPeru new drug registration Rev 8 — approvalNita Deshpande4 d waiting
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.