Our Expertise

Our Turnkey Project Services

Our Contract Research Organization (CRO) specializes in delivering turnkey greenfield and brownfield pharmaceutical projects, covering finished dosage forms, active pharmaceutical ingredients (APIs), and intermediates. From feasibility studies and facility design to regulatory compliance, validation, and commissioning, we provide end-to-end solutions to ensure GMP-compliant, efficient, and future-proof facilities. These services are critical for ensuring product quality, regulatory approvals, and operational excellence, serving pharmaceutical manufacturers, biotech firms, API producers, and CROs aiming to establish or upgrade their facilities.

Pharmaceutical facility construction and design

Our Project Expertise

Feasibility & Planning
📊

Feasibility & Planning

  • Technical & financial viability
  • Site selection & evaluation
  • Business case & ROI planning
  • Regulatory landscape mapping
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Conceptualization & Design
🖼️

Conceptualization & Design

  • Facility layout optimization
  • Modular & prefab design
  • 3D modeling & BIM integration
  • Cleanroom zoning
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Civil & Architectural Design
🏛️

Civil & Architectural Design

  • Detailed engineering drawings
  • Cleanroom ISO classification
  • Seismic & fire safety compliance
  • Construction management
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Process & Utility Engineering
⚙️

Process & Utility Engineering

  • HVAC & water system design
  • PFD & P&ID preparation
  • Automation & SCADA integration
  • Effluent treatment systems
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Equipment Procurement
🛠️

Equipment Procurement

  • Vendor selection & audits
  • FAT/SAT coordination
  • Global & local sourcing
  • Installation & hook-up
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GMP Compliance Consulting
📜

GMP Compliance Consulting

  • USFDA, EMA, WHO compliance
  • URS, DQ, IQ, OQ, PQ
  • Schedule M implementation
  • Mock inspections
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Validation & Qualification

Validation & Qualification

  • Validation Master Plan
  • HVAC & cleanroom validation
  • Process & cleaning validation
  • Computer system validation
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Construction & Commissioning
🏗️

Construction & Commissioning

  • Project management
  • Site supervision
  • Utility commissioning
  • As-built documentation
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Warehouse Design
📦

Warehouse Design

  • GMP-compliant layout
  • Cold & hazardous storage
  • Material traceability
  • Personnel flow design
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EHS Services
🛡️

EHS Services

  • HAZOP & HIRA studies
  • Fire safety & emergency plans
  • Waste management
  • Occupational health programs
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QMS Setup
📋

QMS Setup

  • ICH Q10 QMS development
  • SOPs & BMR/BPR
  • Electronic document systems
  • Training management
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Brownfield Upgrades
🔄

Brownfield Upgrades

  • GMP gap assessments
  • Retrofitting & expansion
  • Tech transfer support
  • Downtime minimization
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Digital Pharma Integration
💻

Digital Pharma Integration

  • SCADA & IoT integration
  • eBMR/eBPR systems
  • Track & trace solutions
  • 21 CFR Part 11 compliance
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Turnkey Project Management
📅

Turnkey Project Management

  • EPCM services
  • Time-cost-quality management
  • Risk mitigation planning
  • Project dashboards
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Post-Handover Support
🤝

Post-Handover Support

  • SOP training & handholding
  • Regulatory inspection support
  • Maintenance planning
  • APR/PQR setup
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Our Project Delivery Process

Feasibility & Planning

We assess project viability, select sites, and map regulatory requirements to create a robust business case.

1

Design & Engineering

We develop GMP-compliant facility designs, including cleanrooms, utilities, and automation systems.

2

Procurement & Construction

We manage equipment sourcing, vendor audits, construction, and quality control to meet project timelines.

3

Validation & Commissioning

We perform validations (DQ/IQ/OQ/PQ) and commission utilities, ensuring regulatory compliance.

4

Handover & Support

We deliver as-built documentation, train personnel, and provide ongoing regulatory and maintenance support.

5

Compliance & Standards

Regulatory Bodies

  • FDA (U.S. Food and Drug Administration)
  • EMA (European Medicines Agency)
  • ICH (International Council for Harmonisation)
  • CDSCO (Central Drugs Standard Control Organization)
  • WHO, PIC/S, TGA, Health Canada, ANVISA

Guidelines & Certifications

  • USFDA, EU GMP, WHO TRS, PIC/S
  • Revised Schedule M
  • ICH Q7/Q9/Q10
  • ISO 14644 (Cleanrooms)
  • 21 CFR Part 11

Applications & Industries

  • Pharmaceutical Manufacturing
  • Biotechnology
  • API & Intermediates Production
  • Contract Research Organizations
  • Contract Manufacturing

Why Choose Our CRO?

Our CRO delivers end-to-end greenfield and brownfield pharmaceutical projects with precision, ensuring GMP compliance, operational efficiency, and regulatory success. With expertise in facility design, validation, and Industry 4.0 integration, we build future-proof facilities tailored to your needs. Partner with us to transform your vision into a compliant, high-performing pharmaceutical operation.

Let’s build something sustainable together →

Frequently Asked Questions

Frequently Asked Questions

What is the difference between Greenfield and Brownfield pharmaceutical projects? +

Greenfield projects are entirely new facilities built from the ground up, while Brownfield projects involve upgrading or expanding existing facilities.

What services are included in a turnkey Greenfield FDF project? +

We cover complete design, engineering, equipment selection, utility integration, validation, and regulatory compliance for finished dosage form manufacturing plants.

Can you help retrofit our existing API facility for regulatory audits? +

Yes. Our Brownfield services include facility revamp, process requalification, documentation alignment, and CAPA support to meet global GMP expectations.

How long does it take to complete a Greenfield project? +

Typical timelines range from 12 to 18 months depending on the size and regulatory scope of the facility.

Do you offer end-to-end compliance support with turnkey execution? +

Yes. We provide design, engineering, execution, and documentation aligned with WHO-GMP, EU-GMP, and other standards to ensure inspection readiness.

What is the scope of your turnkey pharmaceutical project services? +

Our turnkey services cover feasibility studies, facility design, equipment procurement, validation, regulatory compliance, construction, commissioning, and post-handover support for greenfield and brownfield pharmaceutical projects.

How do you ensure GMP compliance in facility design? +

We align facility designs with USFDA, EMA, WHO, PIC/S, and Revised Schedule M guidelines, incorporating GMP-compliant cleanroom zoning, HVAC systems, and validation protocols like DQ, IQ, OQ, and PQ.

What is the typical timeline for a greenfield pharmaceutical project? +

Timelines vary, but a greenfield project typically takes 12–24 months, depending on facility size, complexity, and regulatory requirements. Brownfield upgrades may take 6–12 months.

How do you support brownfield facility upgrades? +

We conduct gap assessments, retrofit designs for GMP compliance, enhance capacity, support tech transfers, and minimize downtime to ensure seamless upgrades.

What industries benefit from your project services? +

Pharmaceutical manufacturers, biotech firms, API producers, and CROs benefit from our services, ensuring compliant facilities for finished dosage forms, APIs, and intermediates.

How do you integrate Industry 4.0 into pharmaceutical projects? +

We incorporate SCADA, BMS, IoT sensors, eBMR/eBPR systems, and 21 CFR Part 11-compliant solutions to enable real-time monitoring, automation, and data integrity.