What are EPCM Solutions?
Our turnkey EPCM services provide end-to-end project management for pharmaceutical facilities, covering engineering, procurement, and construction management, ensuring regulatory compliance and operational efficiency.
EPCM Solutions for Pharmaceutical Projects
Streamline Facility Delivery with Expert Turnkey Management
At Indivirtus Healthcare Services Pvt. Ltd., our EPCM project management services deliver seamless execution of pharmaceutical projects from concept to commissioning. With expertise in Engineering, Procurement, and Construction Management, we ensure GMP-compliant delivery, optimizing safety, efficiency, and compliance.
Why is it Critical?
Effective EPCM ensures timely, cost-effective, and compliant project delivery, minimizing risks and aligning facilities with GMP standards to support product quality and regulatory audits.
Our Role in Your Success
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led project management, streamlining pharmaceutical projects with real-time oversight and proactive risk mitigation for audit-ready outcomes.
Our Expert EPCM Approach
At Indivirtus Healthcare Services, our EPCM solutions are led by seasoned project managers with deep pharmaceutical expertise. We provide comprehensive project oversight, from conceptual design to commissioning, integrating engineering, procurement, and construction management. Our approach includes real-time project dashboards, proactive risk mitigation, and stringent control over time, cost, and quality.
Tailored to your facility’s needs, our services ensure GMP-compliant execution, delivering scalable and efficient solutions that align with global regulatory standards and drive operational success.
EPCM Project Management Deliverables
Detailed Project Execution Plan (PEP): Comprehensive roadmap for project delivery.
EPCM Implementation Strategy: Tailored plan for engineering, procurement, and construction.
Risk Register and Mitigation Plan: Proactive tools for identifying and addressing project risks.
Real-Time Dashboards and KPI Tracking: Dynamic tools for monitoring project performance.
Commissioning and Handover Documentation: Complete records for facility operationalization.
Regulatory Compliance & Global Standards
Our EPCM services align with stringent global standards, ensuring your pharmaceutical projects are audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and operational reliability.
- ICH Q9 – Quality Risk Management: Framework for proactive risk mitigation in projects.
- WHO TRS 961 Annex 6: GMP guidelines for pharmaceutical plant design and operation.
- ISPE Good Practice Guides: Industry best practices for facility project management.
- EU GMP Annex 1: European guidelines for sterile manufacturing compliance.
- US FDA 21 CFR: U.S. regulations for pharmaceutical facility operations.
Applications & Use Cases
Our EPCM project management 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 facility design, equipment installation, and regulatory audits. Key use cases include overseeing turnkey cleanroom projects, ensuring compliance during facility expansions, and streamlining new product manufacturing setups.
Why Choose Indivirtus Healthcare
Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering expert-led EPCM 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 projects to achieve regulatory success and operational excellence, ensuring compliance and efficiency from concept to commissioning.
Frequently Asked Questions
Frequently Asked Questions
What is included in your EPCM turnkey services?
Our EPCM services cover full lifecycle support including design, procurement, vendor coordination, construction oversight, qualification, and handover – all within GMP boundaries.
How do you ensure time and cost control in pharma projects?
We implement detailed scheduling with resource tracking, cost forecasting, and proactive issue resolution to maintain tight control over deadlines and budgets.
What are project dashboards and how do they help?
Our dashboards provide real-time visibility into project KPIs, risk metrics, and progress, enabling better decision-making and quicker responses to deviations.
Do you support regulatory risk management?
Yes, we integrate regulatory risk assessment based on ICH Q9 principles and GMP expectations into every phase of the project.
Can your team handle multi-site project execution?
Absolutely. We have expertise in managing and standardizing multi-site projects while ensuring regulatory harmonization and operational consistency.
What does the EPCM project management service include?
Our service includes end-to-end project management, covering engineering, procurement, and construction management, with detailed project execution plans, risk mitigation, real-time dashboards, and commissioning documentation.
Who benefits from EPCM project management services?
Pharmaceutical manufacturers building new facilities or upgrading existing ones, particularly those requiring GMP-compliant project execution, benefit from our turnkey EPCM solutions.
How does the service ensure regulatory compliance?
Our services align with ICH Q9, WHO TRS 961 Annex 6, ISPE Good Practice Guides, EU GMP Annex 1, and US FDA 21 CFR, ensuring your projects meet global regulatory standards and are audit-ready.
What deliverables are provided with the EPCM service?
Clients receive a detailed Project Execution Plan (PEP), EPCM implementation strategy, risk register and mitigation plan, real-time dashboards with KPI tracking, and commissioning/handover documentation.
Can the EPCM service be customized for our project needs?
Yes, our EPCM solutions are tailored to your project’s specific requirements, including facility type, scale, and regulatory needs, ensuring practical and compliant outcomes.
How does the service support risk mitigation and project tracking?
We provide a risk register with proactive mitigation plans and real-time dashboards for KPI tracking, ensuring tight control over time, cost, and quality throughout the project lifecycle.