Lausen · Basel Area · Switzerland
Swiss Quality. International Experience. Technical Excellence.
QOT Consulting supports pharmaceutical, biotech, medtech and food companies in commissioning, qualification, validation and GMP compliance — from early planning to audit-ready operation. One partner for the entire journey.
02 Why QOT
Built for regulated industries.
Designed for decision-makers.
In GxP environments, the cost of a delayed qualification is measured in lost production days. QOT exists to remove that bottleneck — with seniority, method and speed.
On site · GMP
/ 01
Senior experts only
You work with experienced GMP and validation professionals — not with juniors learning on your project.
/ 02
One partner, end to end
Consulting, engineering, commissioning, qualification and validation connected in a single, continuous workflow.
/ 03
Paperless-first
Risk-based approaches per GAMP 5 and ASTM E2500, digitally documented — audit-ready by design, not by rework.
/ 04
Basel Area, at the source
Based in Lausen, in the heart of Europe's densest life-sciences region — close to your site, your team and your timeline.
03 One Partner · All-in Package
From plan to validated operation — without handover losses.
Most delays happen at the interfaces between project phases. QOT connects the phases that others hand over — one team, one documentation logic, one point of responsibility.
Phase 01
PLAN
Gap analysis, URS review, CQV strategy and master planning.
Phase 02
ENGINEER
Engineering support, design review and technical documentation.
Phase 03
COMMISSION
Installation, start-up and commissioning of systems and utilities.
Phase 04
QUALIFY
DQ / IQ / OQ / PQ for equipment, facilities, utilities and systems.
Phase 05
VALIDATE
Process, cleaning and computer system validation — GAMP 5, Part 11.
Phase 06
OPTIMIZE
GMP routine support, audit readiness and continuous compliance.
04 Services
Four disciplines. One standard: audit-ready.
/ C&Q
Commissioning & Qualification
Equipment, facility, utility and system qualification — from URS to PQ, planned and executed on site.
/ CSV · PV · CV
Validation
Computer system, process and cleaning validation — risk-based per GAMP 5, 21 CFR Part 11 and Annex 15.
/ GMP
GMP & Quality Compliance
GMP consulting, Annex 1 readiness, quality management support and preparation for regulatory inspections.
/ PM · ENG
Engineering & Project Support
Project management, engineering support and technical documentation for CapEx projects in regulated environments.
05 Industries
Wherever quality is regulated, we are at home.
Pharmaceutical
API and drug product manufacturing, aseptic processing, packaging.
Biotechnology
Start-ups and scale-ups taking their first GMP facility into operation.
MedTech
ISO 13485 and MDR environments, cleanrooms, sterilisation processes.
Food & Nutrition
Hygienic production, quality systems and process validation.
Cosmetics & Care
GMP for cosmetics, quality control and compliant production.
06 Selected Project Experience
Experience earned in demanding environments.
Selected project experience of our experts includes assignments involving leading international pharmaceutical, biotechnology and packaging technology companies.
Experience gained by our experts in the course of their professional project work. This does not imply current client relationships or official endorsements. References and project details are available on request, subject to confidentiality.
07 Swiss Quality · International Reach
Swiss-based.
Internationally experienced.
QOT Consulting is based in Lausen, Canton of Basel-Landschaft — in the middle of the Basel Area life-sciences region, home to more than 800 life-sciences companies and one of the world's leading pharmaceutical clusters.
From here, we support projects across Switzerland, the DACH region and beyond — on site and in English, German and French.
08 How We Work
A clear process. No surprises.
Understand
We start with your situation: gap analysis, risk assessment, regulatory scope — before we talk about effort.
Plan
You receive a concrete proposal: scope, milestones, deliverables — as a fixed-fee package or a clearly framed project.
Execute
Senior experts work on site with your team — commissioning, qualification, validation, documentation.
Hand over
You receive audit-ready documentation and a system your own team can run — with optional retainer support afterwards.
Next step
Let's discuss your next project.
Tell us where your project stands — planning, commissioning, qualification or validation. We usually reply within 48 hours.
Discuss a Project