Service 01 / 18 · Feasibility & Strategy
Define the Right Project Before Designing It.
The study converts a product portfolio and target markets into a facility concept that can be costed and compared. Capacity, dosage forms, site options and regulatory targets are assessed together. The result is a recommendation with CAPEX/OPEX ranges, key risks and a realistic schedule.
Engineering phases
Where this service fits
02 / 09 phases in scope
- 01FeasibilityIn scope
- 02ConceptIn scope
- 03Basic Engineeringnot in scope
- 04Detailed Engineeringnot in scope
- 05Procurementnot in scope
- 06Constructionnot in scope
- 07Commissioningnot in scope
- 08Validationnot in scope
- 09Operationnot in scope
Scope
What the service covers
- 01Product portfolio and capacity analysis
- 02Site selection and existing-building assessment
- 03Regulatory pathway and target-market review
- 04CAPEX/OPEX estimation and phasing options
- 05Risk register and investment decision support
Method
From inputs to deliverables
INInputs
05 items- I01Product portfolio and dosage forms
- I02Target markets and forecast volumes
- I03Candidate sites or existing buildings
- I04Investment horizon and budget envelope
- I05Known regulatory targets
WORKActivities
06 items- W01Capacity and shift-pattern modeling
- W02Site and building assessment
- W03Regulatory pathway review
- W04Option development and comparison
- W05CAPEX/OPEX range estimation
- W06Risk identification and phasing analysis
OUTDeliverables
04 items- D-01.01Feasibility report with CAPEX/OPEX ranges
- D-01.02Capacity and batch-size model
- D-01.03Site evaluation matrix
- D-01.04Preliminary project schedule and risk register
Technical detail
What the study examines
Contents · 04
01 / 04
Portfolio & capacity planning
Capacity is derived from the products, not assumed from a floor area.
- Dosage forms and product families
- Annual volumes and batch sizes
- Shift patterns and equipment utilization
- Campaign versus dedicated manufacturing
- Growth scenarios and reserved capacity
02 / 04
Site assessment
- Plot size, shape and access
- Availability of power, water and drainage
- Existing-building condition and structural capacity
- Environmental and neighboring-use constraints
- Room for future expansion
03 / 04
Regulatory pathway
- Target markets and their GMP expectations
- Implications for zoning and cleanliness grades
- Documentation and qualification effort
- Timeline effects of the chosen pathway
04 / 04
Investment case & phasing
- CAPEX/OPEX ranges per option
- Phased versus single-stage delivery
- Key risks and their mitigation
- Realistic schedule to operational readiness
- Recommendation and next-step definition
Deliverables
Typical documents and outputs
- D-01.01Feasibility report with CAPEX/OPEX ranges
- D-01.02Capacity and batch-size model
- D-01.03Site evaluation matrix
- D-01.04Preliminary project schedule and risk register
Services
Related services
- 02
Master Planning & Concept Engineering
Zoning, flows and phasing fixed early, while changes are still inexpensive.
A short description is enough to begin: the products or dosage forms, the expected capacity, the site or building if one exists, the target markets, and the stage the project has reached. Existing studies, layouts or a project brief help us respond with a more precise scope.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700