What are Construction & Commissioning Services?

Our services provide end-to-end project management, on-site supervision, utility commissioning, and robust documentation, ensuring GMP-compliant execution of pharmaceutical facilities from concept to handover.

Why is it Critical?

Effective construction and commissioning ensure facility integrity, regulatory compliance, and operational readiness, minimizing risks and enabling successful audits for global market approvals.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led project execution, coordinating engineering, procurement, and qualification to achieve compliant, high-quality pharmaceutical facilities.

Our Expert Execution Approach

At Indivirtus Healthcare Services, our Construction & Commissioning services are led by experienced project managers and regulatory experts specializing in GMP-compliant execution. We oversee construction timelines, supervise on-site activities, commission critical utilities, and maintain robust documentation to ensure seamless project delivery.

Our collaborative approach integrates engineering, procurement, and qualification teams, delivering audit-ready facilities that align with global standards, ensuring timelines, quality, and compliance are met.

Construction & Commissioning Deliverables

Construction Timelines & Site Execution Plans: Detailed schedules for project execution.

Utility Commissioning Protocols: Comprehensive protocols for critical utility systems.

Daily & Weekly Progress Reports: Regular updates on project milestones and status.

As-Built Documentation & Project Handover File: Complete records for facility operationalization.

Deviation and Change Control Records: Documentation for compliance and audit readiness.

Regulatory Compliance & Global Standards

Our Construction & Commissioning services align with stringent global standards, ensuring your facility is audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and operational reliability.

  • GMP: Global good manufacturing practice guidelines for facility execution.
  • Schedule M (2024): India’s updated GMP requirements for pharmaceutical manufacturing.
  • USFDA 21 CFR: U.S. regulations for pharmaceutical facility operations.
  • EMA GMP Guidelines: European standards for good manufacturing practices.
  • WHO TRS: Global GMP guidelines for quality assurance in facility commissioning.

Applications & Use Cases

Our Construction & Commissioning services are essential for pharmaceutical manufacturers building new facilities or upgrading existing ones to meet GMP standards. Ideal for managing complex projects, our solutions support structural execution, utility commissioning, and regulatory audits. Key use cases include overseeing new manufacturing facilities, ensuring compliance during expansions, and commissioning critical utilities for production.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led construction and commissioning solutions backed by certified project managers with global regulatory experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we streamline your project execution to achieve regulatory success and operational excellence, ensuring compliant and efficient facility delivery.

Frequently Asked Questions

Frequently Asked Questions

What does your construction project management cover?

Our project management covers end-to-end execution, including schedule tracking, resource allocation, contractor coordination, and risk management aligned with pharmaceutical GMP requirements.

Do you offer on-site supervision during construction?

Yes, we deploy experienced site engineers and supervisors to oversee daily activities, ensure safety compliance, and track deviations in real-time.

What utilities do you commission as part of your services?

We handle commissioning of HVAC systems, water systems (PW, WFI), clean steam, compressed air, nitrogen, and other critical process utilities.

What is included in the as-built documentation?

As-built documentation includes final drawings, piping & instrumentation diagrams (P&IDs), equipment layouts, and SOPs validated for GMP compliance.

Do you align construction and commissioning with regulatory inspections?

Absolutely. All execution and documentation are aligned to ensure readiness for regulatory inspections including USFDA, EMA, and WHO audits.

What do Construction & Commissioning services include?

Our services include project management, on-site supervision, utility commissioning, and robust documentation, ensuring GMP-compliant execution from concept to handover.

Who benefits from Construction & Commissioning services?

Pharmaceutical manufacturers building new facilities or upgrading existing ones, particularly those requiring GMP-compliant project execution, benefit from our tailored solutions.

How do these services ensure regulatory compliance?

Our services align with GMP, Schedule M (2024), USFDA 21 CFR, EMA GMP Guidelines, and WHO TRS, ensuring your facility meets global regulatory standards and is audit-ready.

What deliverables are provided with the service?

Clients receive construction timelines, site execution plans, utility commissioning protocols, daily/weekly progress reports, as-built documentation, and deviation/change control records.

Can the services be customized for our project needs?

Yes, our services are tailored to your project’s specific requirements, including facility type, scale, and regulatory needs, ensuring practical and compliant solutions.

How do the services support utility commissioning and handover?

We provide detailed commissioning protocols for critical utilities and comprehensive as-built documentation to ensure seamless handover and operational readiness.