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End-to-End
Engineering Services

From initial advisory through qualification and handover — one single accountable partner across your entire project lifecycle.

Advisory Design & Engineering Turnkey EPCM Qualification & Validation Regulatory Compliance Project Management Advisory Design & Engineering Turnkey EPCM Qualification & Validation Regulatory Compliance Project Management
What We Deliver

Six Core Service Lines

We are a full-spectrum pharmaceutical engineering consultancy. Every service line is designed to work together — delivering a coordinated experience from concept to commissioning under a single accountable partner.

01
Service

Advisory Services

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Our advisory services form the strategic foundation of every project. Before a single brick is laid or a duct is sized, we align your facility concept with regulatory requirements, business objectives, and operational realities — ensuring clarity and confidence from the outset.

Our multidisciplinary experts develop a customised engineering and compliance strategy tailored to your sector and market — ensuring your facility concept is robust, scalable, and audit-ready from day one.

  • Feasibility Analysis
  • Site Master Planning
  • Process Flow Design
  • Risk Assessment & FMEA
  • Regulatory Pathway Alignment
  • Technology Selection
  • Contamination Control Strategy
  • Budget & Schedule Planning
02
Service

Design & Engineering

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Our engineering team translates strategy into GMP-compliant designs using the latest tools including BIM (Building Information Modelling). We cover all disciplines — architectural, structural, HVAC, MEP, and process engineering.

Every design is built to meet global regulatory standards including USFDA, EU GMP Annex 1, WHO TRS, and Revised Schedule M, with full documentation packages ready for regulatory review.

  • GMP/cGMP Facility Design
  • Cleanroom HVAC Engineering
  • AHU & Dehumidifier Design
  • MEP Engineering
  • BIM Modelling
  • Psychrometric Analysis
  • HEPA Filtration Design
  • Pressure Cascade Design
  • Piping & P&ID
  • Electrical & UPS Sizing
03
Service

Turnkey EPCM Solutions

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For clients who want a single-point accountable partner, our Turnkey EPCM offering covers the entire project lifecycle — Engineering, Procurement, and Construction Management.

We turn strategy into BIM-based engineering designs and oversee the entire implementation — from procurement and contractor coordination to construction, installation, and qualification — providing smooth, delay-free delivery.

  • Concept to Commissioning
  • Vendor Selection & Management
  • Procurement Management
  • Construction Oversight
  • Site Coordination
  • Quality Control
  • Schedule Management
  • Handover Documentation
04
Service

Qualification & Validation

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Validation is where engineering design meets regulatory approval. Our team prepares comprehensive DQ/IQ/OQ/PQ documentation packages to meet USFDA, EU GMP, and WHO requirements.

We cover HVAC validation, cleanroom certification to ISO 14644, and equipment qualification — ensuring your facility is fully audit-ready for regulatory inspections.

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • HVAC Validation Protocols
  • ISO 14644 Cleanroom Certification
  • Air Balancing & Testing
  • Validation Master Plan
05
Service

Regulatory Compliance

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Our regulatory compliance team brings decades of experience navigating the world's most demanding regulatory frameworks. We provide gap assessments, compliance audits, and submission-ready documentation.

  • USFDA Pre-Approval Inspections
  • EU GMP Annex 1 Compliance
  • WHO Prequalification Support
  • MHRA Readiness
  • TGA Compliance
  • Revised Schedule M
  • Gap Assessments
  • CAPA Management
  • SOP Development
06
Service

Project Management

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Structured project governance is at the core of everything we do. Our project management methodology ensures complete traceability, accountability, and control at every stage of your project.

  • Project Planning & Scheduling
  • Resource Management
  • Vendor Coordination
  • Budget Control
  • Risk Management
  • Progress Reporting
  • Change Management
  • Closeout Documentation
Compliance Framework

Standards We Engineer To

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

Ready to discuss your project?

Contact us for a no-obligation consultation and project scoping discussion.

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