Premier Pharmaceutical Engineering Consultancy

Concept to
Commissioning.
Globally Compliant.

End-to-end engineering for the world's most regulated industries — pharmaceutical, biosafety, cleanroom, and beyond. From initial feasibility through to final validation, we are your single accountable partner.

15+
Years Expertise
3+
Active Countries
12+
Industry Sectors
100%
Audit-Ready
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USFDA cGMP EU GMP Annex 1 WHO Standards MHRA TGA Australia PIC/S ISO 14644 Revised Schedule M ASME BPE ISO 13485 GEP Practices BIM Modelling DQ/IQ/OQ/PQ ISPE Guidelines USFDA cGMP EU GMP Annex 1 WHO Standards MHRA TGA Australia PIC/S ISO 14644 Revised Schedule M ASME BPE ISO 13485 GEP Practices BIM Modelling DQ/IQ/OQ/PQ ISPE Guidelines
GMP facility floor plan review — Strategix Asia Conseils
Our Story

Engineered for Success.
Built for the Future.

We began with a singular mission — to help highly regulated industries design, build, and operate world-class facilities with the highest standards of safety, compliance, and efficiency.

We blend deep engineering expertise, regulatory insight, and innovative thinking — delivering GMP/cGMP designs, biosafety lab planning, cleanroom systems, and turnkey EPCM solutions across India, New Zealand, and Africa.

Deep Expertise

Decades focused on regulated facility engineering — not generalist consulting.

Regulatory Mastery

USFDA, EU GMP, WHO, MHRA, TGA, PIC/S built into every deliverable.

Full Partnership

Concept to validation — one accountable partner, minimum risk.

Future-Ready

Advanced BIM technology and adaptable design — facilities built to last.

What We Do

End-to-End Engineering Services

From initial advisory to qualification and handover — one single accountable partner.

01

Advisory Services

Feasibility analysis, site master planning, process flow design, risk assessments, and regulatory pathway alignment.

02

Design & Engineering

GMP/cGMP compliant facility design, cleanroom HVAC, MEP engineering, BIM modelling, and detailed documentation.

03

Turnkey EPCM Solutions

Complete engineering, procurement, and construction management. Single-point responsibility for smooth delivery.

04

Qualification & Validation

Full DQ/IQ/OQ/PQ documentation, HVAC validation, cleanroom certification to ISO 14644.

05

Regulatory Compliance

Expert guidance through USFDA, EU GMP, WHO TRS, MHRA, TGA, Revised Schedule M, and PIC/S.

06

Project Management

Structured governance, vendor management, schedule control, and site coordination for on-time delivery.

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Pharmaceutical manufacturing campus — Strategix Asia Conseils
Industries We Serve

Sectors Built
on Deep Expertise

We specialise exclusively in sectors where precision engineering and regulatory compliance are non-negotiable.

Pharmaceuticals

Pharmaceuticals

GMP facility design and full validation.

Biopharmaceuticals

Biopharmaceuticals

cGMP biotech and bioreactor facilities.

Biosafety Labs

Biosafety Labs

BSL-3 and BSL-4 containment design.

Nutraceuticals

Nutraceuticals

Ayush-certified GMP design.

Cosmetics

Cosmetics

ISO-compliant manufacturing facilities.

Hospital & Healthcare

Hospital & Healthcare

HVAC engineering for OT suites.

Warehouse & Packaging

Warehouse & Packaging

GDP-compliant cold chain design.

Industrial & FMCG

Industrial & FMCG

MEP engineering for industrial plants.

Compliance Framework

International Standards
We Engineer To

Compliance is engineered in from day one — not checked at the end.

USFDA cGMP
EU GMP Annex 1
EU GMP Annex 2
WHO TRS
MHRA
TGA Australia
PIC/S
ISO 14644
ISO 13485
Revised Schedule M
ASME BPE
ISPE
GEP
Ayush Guidelines
NBC 2016
IS 732 / IS 3043
How We Work

Our Proven Project Process

01

Strategy & Feasibility

Site master planning, regulatory pathway analysis, process flow design, and risk assessments.

02

Design & Engineering

GMP-compliant detailed design, BIM modelling, HVAC, MEP, and all-discipline documentation.

03

Construction & Delivery

Procurement, construction oversight, vendor management — single-point EPCM accountability.

04

Qualification & Handover

DQ/IQ/OQ/PQ validation, commissioning, regulatory documentation, and post-project support.

Ready to start your project?

Tell us about your facility requirements and we'll get back to you within 24 hours.

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