What are Feasibility & Planning Services?

Our services offer comprehensive feasibility studies, including technical and financial viability analysis, site selection, ROI forecasting, and regulatory risk mapping, ensuring GMP-compliant facility development.

Why is it Critical?

Strategic planning ensures project viability, regulatory compliance, and optimized ROI, minimizing risks and aligning facility development with global standards for long-term success.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led planning solutions, guiding pharmaceutical companies to create scalable, compliant facilities with confidence and efficiency.

Our Expert Planning Approach

At Indivirtus Healthcare Services, our Feasibility & Planning services are led by seasoned consultants with global regulatory expertise. We conduct thorough technical and financial viability analyses, evaluate site suitability, and map regulatory risks to align with USFDA, EMA, and WHO standards. Our tailored roadmaps ensure your facility meets compliance and ROI objectives.

Our approach integrates data-driven insights and practical strategies, delivering scalable and future-ready plans that support Greenfield or Brownfield projects, ensuring regulatory readiness and operational efficiency.

Feasibility & Planning Deliverables

Feasibility Assessment Report: Comprehensive analysis of project viability and risks.

Technical and Financial Analysis: Detailed evaluation of project feasibility and costs.

Site Evaluation Matrix: Structured assessment for optimal site selection.

Business Case with ROI Forecast: Strategic plan with financial projections.

Regulatory Risk Map: Framework for navigating global compliance requirements.

Regulatory Compliance & Global Standards

Our Feasibility & Planning services align with stringent global standards, ensuring your facility development is regulatory-compliant and ready for international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance confidence and compliance.

  • ICH Q9 – Quality Risk Management: Framework for proactive risk assessment in planning.
  • WHO TRS 1019 Annex 2: Global GMP guidelines for facility design.
  • USFDA/EMA Facility Design Considerations: U.S. and European standards for pharmaceutical facilities.
  • ISPE Baseline Guides: Industry best practices for facility planning and design.
  • EU GMP Annex 1: European guidelines for sterile manufacturing compliance.

Applications & Use Cases

Our Feasibility & Planning services are essential for pharmaceutical companies developing Greenfield or Brownfield projects. Ideal for site selection, regulatory alignment, and ROI optimization, our solutions support new facility setups, expansions, and compliance upgrades. Key use cases include planning GMP-compliant manufacturing sites, navigating regulatory requirements for global markets, and ensuring cost-effective project execution.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical companies, delivering expert-led feasibility and planning solutions backed by certified consultants 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 empower your facility development with robust, compliant, and scalable plans, driving regulatory success and long-term operational excellence.

Frequently Asked Questions

Frequently Asked Questions

What does technical and financial viability include in pharmaceutical feasibility?

It involves assessing engineering practicality, capacity planning, technology fit, cost modeling, CAPEX/OPEX estimation, and break-even analysis to determine project success probability.

How is site selection performed for a new pharma facility?

Site selection includes evaluation based on proximity to suppliers, logistics, utility availability, workforce, regulatory requirements, and environmental risk to determine suitability.

Why is a business case with ROI essential in early-stage planning?

A business case helps justify the investment by projecting costs, returns, timelines, and potential risks, enabling stakeholders to make informed go/no-go decisions.

What is covered under regulatory landscape mapping?

It involves identifying all applicable local and international regulations (e.g., USFDA, EMA, WHO), zoning laws, permitting, and GxP requirements for facility setup and operations.

How long does a feasibility study typically take?

A standard feasibility and planning study for pharma facilities takes 4 to 6 weeks, depending on project complexity, data availability, and number of site options under consideration.

What do Feasibility & Planning services include?

Our services include technical and financial viability analysis, site evaluation, ROI forecasting, regulatory risk mapping, and a comprehensive feasibility assessment to support GMP-compliant facility development.

Who benefits from Feasibility & Planning services?

Pharmaceutical companies developing Greenfield or Brownfield projects, seeking regulatory compliance, site selection, or ROI optimization benefit from our strategic planning solutions.

How do these services ensure regulatory compliance?

Our services align with ICH Q9, WHO TRS 1019 Annex 2, USFDA/EMA Facility Design Considerations, ISPE Baseline Guides, and EU GMP Annex 1, ensuring compliance with global regulatory standards.

What deliverables are provided with the service?

Clients receive a feasibility assessment report, technical and financial analysis, site evaluation matrix, business case with ROI forecast, and a regulatory risk map.

Can the planning services be customized for our project needs?

Yes, our services are tailored to your project’s specific requirements, including site selection, regulatory needs, and financial goals, ensuring practical and compliant solutions.

How do the services support ROI optimization?

We provide detailed financial analysis and ROI forecasting, aligning facility planning with cost-effective strategies to maximize returns while ensuring GMP compliance.