The challenge
Before a single vial is filled, a pharma manufacturing project needs a feasibility package: which equipment, at what capacity and cost, in which rooms, under which compliance requirements.
Today that package is assembled by hand — equipment matrices in spreadsheets, room lists in Word, compliance mapped cell by cell against US FDA 21 CFR Part 211 and India's Revised Schedule M. It is slow, expensive, inconsistent between projects, and nearly impossible to regenerate when the drug portfolio changes.
What we did
PharmaLaunch takes a drug portfolio as input and generates the core planning documents of a facility project. Generation is AI-driven, but every document passes a deterministic rule engine and automated PASS/FAIL quality gates before it reaches you — the discipline of a GMP document, applied to the software that writes it.
Four modules: an Equipment Matrix Generator (tiered options with server-computed volumes and rule-filled compliance columns), a Room Register & Facility Layout Generator (product-agnostic, ~29 quality gates per run), a GMP Documentation Engine (SOPs aligned to 21 CFR Part 211 and Revised Schedule M), and Patent Intelligence (in development).
Numbers, compliance flags, and quality gates are computed server-side — never guessed by the model.
Where it landed
Validated against a real reference case: a facility making Artesunate 60 mg/vial and Pantoprazole 40 mg/vial — both sterile injectables, the hardest documentation class in pharma.
One run produced a 114-row equipment matrix (2 drugs × 19 sterile-parenteral operations × 3 equipment tiers), PASS-verified against a 120-row human-built reference sheet, plus the full room and layout package under ~29 automated quality gates, and a complete manufacturing SOP aligned to 21 CFR Part 211 and Revised Schedule M.
Documents that normally take weeks of consulting are generated in a single run — and regenerated when the portfolio changes. The platform is in private validation with early access opening; PharmaLaunch LLP is being incorporated in India.
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