Engineering Design and Construction

Strategy Before Design.

A project’s success is often decided in its definition stage. We provide the preliminary consulting and feasibility studies necessary to transform raw ideas into structured, investment-ready plans.

By performing rigorous analysis early, we help you secure clear advantages and avoid mistakes before construction-ready designs are even started.

Key services areas at this stage include:

• Preliminary Consulting – Project evaluations and feasibility studies.
• Investment Strategy – Support in defining new equipment and manufacturing plant investments.
• Optimization & Redesign – Consulting for regulated processes and facility improvements.
• Technical Integrity – Technical due diligence and definition of technical specifications.
• Compliance & Requirements – Development of User Requirements Specifications (URS) alongside GMP and ISO compliance reviews.

From concept to construction readiness.

Our design services are tailored to your specific quality requirements and economic targets.

There are 3 design stages as your project progresses:

1. Conceptual Design – Optimizations and analysis.

• Preliminary Project Layout & Process Definition
  Optimized arrangement of premises and processes for maximum operational efficiency.
• Personnel & Material Flow Design
  Streamlined In/Out flows to enhance productivity, safety and compliance.
• Utilities & Instrumentation Identification
  Block-diagram mapping of thermal, electrical systems, instruments, and required capacities.
• Technical Intervention Report
  Detailed description of planned modifications and upgrades.
• Implementation Timeline.
  Clear schedule of key macro-activities via Gantt chart for effective project planning.
• Economic Investment Estimate

2. Basic Design – The foundations for precise execution.

• Project Coordination
  Structured project governance to ensure alignment across teams and disciplines.
• HSE/SCP
  Guidance to navigate health, safety, and environmental compliance seamlessly.
• Updated Process Flow Diagrams & Utility Block Diagrams
  Clear visualization of process and utility line integration.
• Updated P&IDs for Main Utilities & Process Lines
  Accurate, validated schematics for smooth execution.
• Clean Room & Plant Layouts for Civil Works
  Optimized spatial organization for efficiency, safety, and GMP compliance.
• Equipment & Instrument Lists
  Comprehensive inventory supporting procurement and project planning.
• Utilities List & Preliminary Bill of Quantities
  Detailed resource planning for budgeting and execution.
• Basic Engineering Gantt Chart
  Detailed planning of engineering activities for on-time delivery.

3. Detail/ Executive Design – Detailed planning for construction.

• Project Coordination
  Integrated project governance ensuring seamless alignment across all disciplines.
• Detailed Engineering Gantt Chart
  Precise scheduling of engineering activities to meet timelines and milestones.
• Detailed PFD & P&Id for Utilities & Process Lines
  Accurate schematics enabling reliable implementation and operational efficiency.
• Updated P&IDs for Main Utilities & Process Lines
  Accurate, validated schematics for smooth execution.
• Civil & Structural Engineering Detailing
  Comprehensive design ensuring structural integrity, compliance, and constructability.
• Piping Engineering Detailing
  Optimized layouts for safety, efficiency, and maintainability, ensuring all piping is interference free.
• Mechanical Engineering Detailing
  Complete design of mechanical systems supporting performance and reliability.
• Electrical Engineering Detailing
  Power distribution and control systems designed for operational excellence.
• Instrumentation & Automation Engineering Detailing
  Advanced control and monitoring solutions for precision.

We have two modes of operation for the delivery of projects worldwide:

1. For international projects we manage the Define and Design phases, ensuring seamless delivery through our established global network.
2. For projects in Italy and Switzerland where we have a presence and can control costs, materials, and other variables
   we can construct and deliver on either an EPC or EPCM basis.

Our construction work is in full compliance with the latest GMP, ISO, FDA, and Best Engineering Practices.

Plant facilities are designed and built to achieve applicable local and Global approvals, with end-to-end support for project management, works supervision, and safety coordination as required.

The difference between EPC and EPCM projects:

EPC (Lump Sum Turnkey) – Acting as General Contractor (GC), will take responsibility for the entire work as follows, once completed the Engineering (E) part.

Procurement (P): in which the GC will support client by advising on suitable Vendors, and executing the technical alignment for the necessary purchases.

Construction Management (CM): in which the GC will supervise the entire construction, commissioning and plant qualification phases.

EPCM (Lump Sum Turnkey) – Acting as General Contractor (GC), will take responsibility for the entire work as follows, once completed the Engineering (E) part:

1. 1. Procurement (P): in which the GC will support client by advising on suitable Vendors, and executing the technical alignment for the necessary purchases.
   2. Construction Management (CM): in which the GC will supervise the entire construction, commissioning and plant qualification phases.

As part of the delivery process for both EPC and EPCM projects we perform the formal documented verification of a facility’s core assets according to established Qualification and Validation protocols.

It ensures that all systems are not only physically present but are performing exactly as intended to meet high-stakes industry requirements.

The scope of this verification covers:

• Essential Equipment – Individual machinery and local tools required
  for the manufacturing process.
• Plant Utilities – Critical support systems, such as water, HVAC, and technological gases that must maintain specific environmental standards.
• Production Lines – Integrated manufacturing paths that require end-to-end synchronization and reliability.

Key process areas

• Validation & Qualification – Systematic testing (typically including DQ, IQ, OQ, and PQ) to confirm that equipment and utilities are installed correctly and function consistently under production conditions and applicable regulations.
• Data & Compliance Excellence – Rigorous documentation ensures that all data generated during the process meets regulatory expectations for integrity, transparency and traceability.
• Energy, Waste, and Maintenance – A transition from initial validation to long-term site maintenance services, ensuring the infrastructure remains in a qualified state throughout its lifecycle.

This rigorous approach allows for the delivery of local turnkey projects or expert consulting for global constructors, ensuring the right service is provided for your specific requirements at every stage.