PRE-MARKET · GAP ANALYSISSYNTHETIC DATARA LEAD · DRUG
Gap Analysis & Go / No-Go
What is missing from the dossier before anything is submitted, what it costs to close, and the decision that ends the pre-market stage.
PRE-MARKET
A gap is not a deficiency
A gap is something missing from the dossier, found before anything is submitted — it belongs here, in pre-market, and it ends in a go or no-go decision. A deficiency is a question an authority raises after submission, and that lives on Deficiency & HAQ in post-market. Keeping the two apart is what makes either number mean anything.
Gap Analysis
Run at dossier audit, before the deal is concluded — a gap is a risk on taking the project at all.
Zone 4B stability study
NEEDS REVIEWSupplier confirmed it verbally to BD, but the European dossier shared at audit carries Zone 2 only.
Vietnam · PhilippinesSupplier
HPLC chromatograms, related substances
NEEDS REVIEWEvaluator asked for 20 percent chromatograms — not part of the routine analysis package.
VietnamSupplier
Raw batch analysis data
ACTIONHeld separately per batch by the team; the market rule requires it with the COA.
PhilippinesRA Ops, Mumbai
Certified annex translations
ACTIONNational permit requires certified translation; currently done at local level after download.
EthiopiaCertified translator
Site GMP certificate
WATCHExpires inside the review window; renewal filing not started.
KenyaQA, Bangkok
Go / No-Go Decision
The gate at the end of pre-market. Gap analysis produces a position per market; a human decides whether the opportunity justifies closing the gaps. A no-go ends that market here, with the reason on the record rather than the file quietly sitting open.
VietnamGO
GAPS OPEN2COST TO CLOSE$48kADDS+4 mo
Zone 4B study is fundable and the forecast carries it. Existing registration gives the renewal a shorter path than a new filing.
R. MENON · BD02 AUG 2026
PhilippinesGO
GAPS OPEN3COST TO CLOSE$31kADDS+3 mo
Raw batch records exist at the plant and were never scanned. Cost is scanning and review, not new science.
R. MENON · BD11 AUG 2026
UzbekistanHOLD
GAPS OPEN4COST TO CLOSE$62kADDS+9 mo
Sole certified translator for Uzbek sets the floor on timeline. Held until a second provider is qualified.
AWAITING BDOPEN 18 DAYS
EthiopiaNO-GO
GAPS OPEN6COST TO CLOSE$140kADDS+14 mo
Requires a bridging BE study the forecast cannot carry. Closed with the reason recorded; revisit if the national permit changes.
R. MENON · BD24 JUL 2026
A go moves the product into market: the master dossier is finalised, then compiled into that market's grammar as a market dossier. Only after submission does anything on this product become a deficiency.
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.