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.