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About Us

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We engineer decisions regulators approve.

who we are

Not an EPC. An independent design authority.

Inotek is a specialist consulting firm that sits between pharma manufacturers and the regulatory world — holding design authority accountable to GMP logic, not construction convenience.

Engineering Intelligence

Engineering Intelligence

Conceptual to detailed engineering packages — built around inspection readiness, not just drawings.

Regulatory Architecture

Regulatory Architecture

Every facility defined by a structured GMP framework — before a single brick is laid.

Compliance Outcomes

Compliance Outcomes

Measured through validation clarity, documentation integrity, and inspection performance.

Global Regulatory Exposure

Global Regulatory Exposure

Experience across USFDA, EU-GMP, WHO, PIC/S, and other regulated markets.

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Years Experience

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Continents Served

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Regulatory-First

Regulatory thinking leads every design decision.

At Inotek, compliance is not a checklist applied at the end. It is the lens through which every square metre is designed. We call this regulatory-first engineering.

Regulatory Background

FRAMEWORK

Before engineering starts, we define the inspection boundary.

Before engineering starts, we define the inspection boundary.
Before engineering starts, we define the inspection boundary.

Zoning and flow decisions are mapped against GMP logic.
Zoning and flow decisions are mapped against GMP logic.

Technical systems are aligned to risk and qualification intent.
Technical systems are aligned to risk and qualification intent.

Evidence pathways are designed in, not added later.
Evidence pathways are designed in, not added later.

Design integrity is maintained through execution and handover.
Design integrity is maintained through execution and handover.

Why not just another EPC?

EPC contractors optimise for cost and schedule. Inotek optimises for regulatory outcomes. The difference shows up on inspection day — not delivery day.

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Risk based Design approach

Risk based Design approach

Before any design begins, we define the regulatory envelope — the non-negotiable GMP boundaries that govern every layout decision.

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Detailed 3D modeling

Detailed 3D modeling

Before any design begins, we define the regulatory envelope — the non-negotiable GMP boundaries that govern every layout decision.

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Faster turnaround time due to pre validated designs

Faster turnaround time due to pre validated designs

Before any design begins, we define the regulatory envelope — the non-negotiable GMP boundaries that govern every layout decision.

Indian roots. Global reach.

Headquartered in Thane with a technical centre in Noida, Inotek serves pharmaceutical manufacturers across India, the GCC, Africa, and Southeast Asia. Indian engineering rigour. International regulatory literacy. The same standard of design authority — regardless of geography.

A-208, 2nd Floor, Hamilton, Hiranandani Estate, GB Road, Thane – 400 607, Maharashtra, India.

India Headquarters
India Technical Center
Singapore Regional Office
Hanoi Regional Office
Dubai Regional Office
Pennsylvania Regional Office

Get in touch

Let's explore the possibilities together.

Tell us about your facility — where it's going, what it needs to achieve. We'll tell you where the structural risks are.

Lets talk
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