You co-author the route
You enter the inputs yourself via the intake form: dosage forms, therapeutic groups, manufacturing route, region. The first feasibility map is built on that data.
Online service · projects worldwide
Your idea. Our verified plant plan.
Molecule, formulation, plant, regulatory, economics — one council, one route.
Council · the roles
One idea, examined from eight angles at once
Medicinal chemistry
Protein engineering
Formulation
Plant engineering
Regulatory
Clinical pharmacology
Financial modelling
Fact-checking
Med-chem · live model
A real docking pose of a candidate in the binding pocket.
See the live modelTrust screening
Strong claims are replaced with clear boundaries
Investors and operating leaders need to know what we do — and just as much, where our role ends. That is why the early stage runs on evidence, risks and decision gates.
Decision documents
Each phase ends with a decision package: stop, pivot, proceed to concept design, or open the CAPEX gate.
Regulatory boundaries
We do not promise regulatory approval or a successful inspection; we prepare the technical, GMP and documentation basis for assessment.
Local expertise
We handle legal opinions, MAH questions, licensing and official submissions together with local counsel and regulatory representatives where needed.
Project line
From idea to launch — one transparent route
One line instead of scattered services. Each stage ends with a decision and a document, not generic advice. We do not promise regulatory approval — we prepare the technical, GMP and documentation basis on which decisions are made and investors are won.
We work with
Oral solid dosageSterile fill-finishAPIs and intermediatesBiotech and biologicsPackaging and secondary operationsSupplements & nutraceuticalsAdjacent regulated clean manufacturing
01
DOC-01Idea
- we do
- We review the product, demand, competitors, barriers to entry and target markets.
- ◇ decision
- Stop · pivot · proceed
- deliverable
- Feasibility memorandum
02
DOC-02Feasibility
- we do
- We model market, jurisdiction, unit cost and demand — with the same engine as the first screen.
- ◇ decision
- Open the CAPEX gate?
- deliverable
- Feasibility map + budget range
03
DOC-03Factory concept
- we do
- Process scheme, capacity, personnel and material flows, clean zones, utilities.
- ◇ decision
- Layout and site
- deliverable
- GMP concept + risk register
04
DOC-04Engineering & URS
- we do
- User requirements, tender packages, comparison matrices, FAT/SAT criteria.
- ◇ decision
- Which equipment to buy
- deliverable
- URS + vendor-selection package
05
DOC-05Dossier
- we do
- DMF/ASMF, CTD Module 3 inputs, SOPs, specifications, master plans for the market.
- ◇ decision
- Regulatory pathway
- deliverable
- DMF / ASMF / CTD inputs
06
DOC-06CQV & validation
- we do
- Commissioning, IQ/OQ/PQ, process validation, training, technology transfer.
- ◇ decision
- Inspection readiness
- deliverable
- CQV plan + gap assessment
07
DOC-07Launch
- we do
- Inspection and go-to-market preparation, final package review.
- ◇ decision
- Go-live
- deliverable
- Package for the next investment stage
Projects
Real de-risking cases — anonymized under NDA
Task → method → result, with numbers from project reports.
Plant engineering
Independent HVAC & chilled-water check for a GMP plant
A 137 kW double-count and 22 deviations from spec — before the contract.
View caseMarket-entry economics
Generic launch: the sales plan vs the ceiling of demand
The 50,000-pack plan was the ceiling of all demand; entry as a business loses money.
View caseMedicinal chemistry
Selectivity read: 1401 antagonists to 19 confirmed
A manual check filtered false hits and brought two methods into agreement.
View caseFirst-pass estimate
Build a first-pass feasibility map
Mark forms, groups, route and region — the engine shows an indicative timeline, CAPEX and regulatory pathway.
First-pass feasibility map · ready
Region
CAPEX
6–18 M USD
Manufacturing class
Oral solid dosage (OSD)
Climate · stability program
Zone II — subtropical (25 °C / 60 %)
Regional indication — exact zone confirmed per country (Central Asia may be IVb).
Indicative estimate from your inputs. Ranges are deliberately wide — exact figures are computed in the diagnostic session.
Project intake ↓Beyond GMP — the full GxP scope
Designed for inspection assessment, market entry and scale
GMP is only part of it. We cover the full GxP scope: GMP, GLP, GCP, GDP and data integrity. We first define where the product will be manufactured, sold and assessed, then set the applicable scope, engineering depth, validation depth and documentation depth.
EU GMP / EudraLex Volume 4EU GMP frameworkFDA Drug Master FilesDMF submissions and resourcesFDA process validationFDA lifecycle validationICH Q8, Q9(R1), Q10quality, QRM, PQSWHO GMPmain GMP principlesPIC/S PE 009 publicationsinspection harmonizationISO 14644 cleanroom seriesIEST overview of cleanroom standardsISPE GAMP 5industry guidance for computerized systemsGLP — 21 CFR Part 58good laboratory practiceGCP — ICH E6good clinical practiceEU GDPgood distribution practiceData integrity — 21 CFR Part 11electronic records, ALCOA+Supplements — 21 CFR Part 111dietary supplement cGMP
Project intake
Build your manufacturing profile
Mark what you plan to produce and where you are heading. You are a co-participant: the first feasibility map is built on your inputs.
Step 1 of 617%
Which dosage forms do you plan?
Select all that apply.
Not sure? Skip the step — we will cover it in the diagnostic session.
Project start
Bring a product, market or factory idea
The first session captures the product, target countries, intended manufacturing format, investment constraints and the nearest management decision.
First output
A short feasibility map: product, target market, applicable GMP scope, documents, budget range and the next 90 days.
- NDA if the product or technology is sensitive
- 30-45 minute diagnostic session
- data request: product, market, capacity, timeline, budget constraints
- feasibility memorandum and 90-day route map