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.
Your manufacturing idea. Our verified plant plan.
End-to-end pharmaceutical engineering
We screen production ideas for selected target markets, build GMP-oriented factory concepts, model economics, and prepare URS, dossier inputs and CQV packages where they apply.
Intake form
you enter dosage forms, therapeutic groups, route and region yourself
Gate 0
product, market, GMP scope and CAPEX screening before design spend
URS→CQV
documentation tied to equipment, risks and validation
NDA
confidential start for sensitive products and technologies
Trust screening
Strong claims are replaced with clear boundaries
Investors and operating leaders need to know not only what we do, but where our role ends. The early stage is therefore built around 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
Legal opinions, MAH questions, licensing and official submissions are handled with local counsel and regulatory representatives where needed.
Full cycle
One integrated workstream instead of scattered consultants
We connect technology, GMP, equipment selection, commercial screening and financial modelling. Regulatory work is scoped to the selected market and product, without promising one universal document for every country.
Manufacturing idea screening
We review the product, demand, competitors, barriers to entry, target markets and launch feasibility before the first CAPEX decision.
Jurisdiction and regulatory route
We compare FDA cGMP, EU GMP/EudraLex, applicable ICH approaches, WHO GMP, PIC/S PE 009 and requirements of selected local authorities.
Factory concept and technology
We define the process scheme, capacity, personnel and material flows, clean zones, utilities and critical risk points.
GMP by design
We embed quality into layout, equipment, the pharmaceutical quality system, change control, qualification and process validation from the earliest stage.
URS, procurement and vendors
We prepare user requirements, tender packages, comparison matrices, FAT/SAT criteria and technical rationale for selected solutions.
Dossier and documentation
We prepare DMF or ASMF, CTD Module 3 inputs, SOPs, specifications, protocols and master plans where applicable to the product and market.
Financial model and market route
We model CAPEX/OPEX, unit cost, demand scenarios, price corridors, competitive positioning and go-to-market logic.
CQV and launch readiness
We support CQV planning: commissioning, IQ/OQ/PQ, training, technology transfer and gap assessment before inspection readiness reviews.
Working route
Evidence first. Then design, procurement and CQV.
At the early stage, the priority is to quickly separate an attractive idea from one that is technically, regulatory and economically feasible. So we start not with a pitch, but with your inputs — through a short project intake form.
Oral solid dosage
Sterile fill-finish
APIs and intermediates
Biotech and biologics
Packaging and secondary operations
Adjacent regulated clean manufacturing
1
Define product and target market
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
2
Screen the regulatory and commercial route
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
3
Build the process scheme and factory concept
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
4
Model economics, risks and timeline
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
5
Package GMP documents, URS, dossier inputs and CQV
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
6
Prepare the next investment decision package
Each decision is captured in a document, calculation or risk matrix so the next phase rests on evidence rather than optimism.
Documents and decisions
You receive a decision package, not a slide deck
The value is a coherent set of documents that can support investor conversations, site selection, vendor tenders, discussions with local regulatory advisors and CQV planning.
1Idea
Feasibility memorandum
market, jurisdiction, regulatory barriers, unit cost, demand, competitive map
2Concept
GMP manufacturing concept
technology, layout, flows, cleanliness classes, utilities, risk register
3Equipment
URS and vendor-selection package
user requirements, tender scope, comparison matrix, FAT/SAT criteria, lifecycle cost
4Dossier
DMF/ASMF/CTD inputs
documents applicable to the market and manufacturer role: Module 3, SOPs, VMP, protocols
5Readiness
CQV and inspection-preparation plan
IQ/OQ/PQ, process validation plan, training, technology transfer, gap assessment
Regulatory architecture
We shape the route for a specific market: from site requirements to the structure of the registration package.
Engineering math
We turn the manufacturing hypothesis into capacity, rooms, equipment, utility loads, CAPEX and timelines.
Quality system logic
We build in PQS, risk management, change control, validation lifecycle and the documentary trail from day one.
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+
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.
Build the initial briefContact us directly
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.