Board-Ready Lab Investment Memorandum in 30 Minutes

The tool covers 6 laboratory segments: Clinical Diagnostics, Food Safety, Pharmaceutical, Oil & Gas, Chemical, and Forensic Science. Each has a specialized questionnaire, instrument database, and industry benchmarks. The resulting Investment Memorandum includes equipment recommendations, CAPEX/OPEX analysis, staffing, real estate assessment, and workflow optimization.

Not every laboratory needs a clean room. Basic QC and analytical labs operate under ISO 17025 or GLP without classified environments. Clean rooms become mandatory when your processes involve sterile pharmaceutical manufacturing, aseptic filling, or medical device assembly. Our Environment Level Assessment helps you determine exactly which classification, if any, applies to your facility.

ISO 13485 is the quality management standard for medical device manufacturers. If you design, produce, install, or service medical devices, you need ISO 13485 certification. This typically requires at minimum a controlled environment (ISO 8 / Grade D). Our framework maps the specific requirements to your product type and regulatory market.

The framework covers 5 major regulatory families: ISO 17025 (testing labs), ISO 13485 (medical devices), ISO 14644 (cleanroom classification), EU GMP Annex 1 2022 (sterile pharma), and FDA 21 CFR 210/211 (US pharma). Additional coverage includes WHO TRS 937, PIC/S, and GLP for specific lab types.

The upgrade path depends on your target classification. Moving from a basic lab to Grade D (ISO 8) requires HVAC upgrades, pressure differential monitoring, and environmental controls, typically a €350K–€1.5M investment. Our Environment Level Assessment identifies exactly what your current facility needs and provides a phased upgrade plan with budget estimates for each stage.

Yes. The questionnaire and the PDF are free and carry no obligation. Preliminary planning of this depth is otherwise billed in consultant days. We offer it free because better-planned laboratories lead to better procurement decisions. If you want KombiMED engineers to review the result or plan the project with you, that is a separate, optional service. Your data is confidential and never shared with vendors.

Every instrument that fits a required category gets a score out of 100: 40 % throughput fit (device size against your monthly sample volume), 25 % automation fit (your stated preference, including manual or semi-automatic), 20 % model recency and 15 % global service network of the brand. The highest score is the primary recommendation; up to four next-best models are listed as alternatives you can swap in. No manufacturer pays for a better score.

Every answer is saved as you go: when you move to the next section and a few seconds after you type. A copy also stays on your device. Open the questionnaire again and choose “Continue where I left off”; answers entered while offline are sent as soon as the connection is back.

A laboratory investment memorandum is a structured planning document that translates a laboratory's technical, clinical or manufacturing requirements into a costed and compliance-mapped investment plan suitable for board approval or bank financing. It covers CAPEX and OPEX, equipment recommendations, staffing, site assessment, clean-room classification and regulatory mapping. KombiMED's tool generates it from a structured assessment of 38–44 questions.

Grade A (ISO 5) is the highest GMP classification, required for aseptic processing and sterile filling. It is the most expensive environment to build and validate. Grade D (ISO 8 at rest) is a controlled environment for less critical steps, for example non-sterile pharmaceutical production or medical-device assembly. Choosing the grade the process actually needs is the most consequential cost decision in clean-room construction.

Costs depend mainly on the GMP classification and the floor area. As KombiMED planning estimates: a basic QC laboratory without GMP classification (about 200 m²) costs roughly €120K–€500K; a full pharmaceutical production facility at ISO 5 / Grade A (about 2,000 m²) roughly €7.2M–€27.5M, including construction, equipment, validation and contingency but excluding land.

No. The framework maps against international standards (EU GMP, ISO, FDA) and applies anywhere. KombiMED's own project experience (125+ projects in 18+ project countries) is concentrated in Central Asia, the Caucasus and Eastern Europe; for other regions the financial benchmarks should be adjusted to local construction costs.