For pharma, biotech and medtech companies
QMVP supports regulated companies with computerized system and software validation (CSV/CSA), assessment and validation of AI systems in GxP environments, and qualification and validation (CQV) – using a risk-based, practical approach with clearly defined deliverables.
Why QMVP Consulting?
QMVP combines regulatory expertise with practical project work. We structure complex requirements and translate them into clear approaches, agreed work packages and traceable documentation.
Technical questions and necessary adjustments are discussed directly with the people assigned to the agreed work package.
Visible in your project through
Named contacts and direct technical coordination
CQV for production systems and equipment and computerized system validation are coordinated at their technical interfaces.
Visible in your project through
Consistent user requirements, responsibilities and documentation across system boundaries
Recommendations become defined work packages, responsibilities and usable results – from planning and assessment through documentation.
Visible in your project through
Plans, protocols, assessments and reports as agreed deliverables
Assessments, assumptions, deviations and open points are documented and agreed in a traceable way within the agreed deliverables.
Visible in your project through
Documented decisions, assessed deviations and clearly identified open pointsHow collaboration begins
In our first discussion, we clarify the current situation, project objectives, existing documents, timeframe and roles. Technical questions are discussed directly with the people who will work on the project.
Would you like to discuss your project needs with us?
Discuss your projectFAQ
From qualification and validation planning through testing and documentation to technical review before project closure. For existing production equipment and systems, we can also carry out periodic reviews and agreed requalification or revalidation activities. You can engage us for individual tasks or several project stages.
Yes. We assess existing documentation, usable results and open points. Together, we then define the next steps and the remaining scope. Incomplete documentation can be the starting point.
Yes. We prepare documents, plan and execute agreed tests, and assess results and deviations. Before starting, we agree which tasks we will undertake and what your team needs to provide. This includes designated contacts, existing documentation, required system access and approvals. Operator responsibility and final approvals remain with you.
Our experience covers production equipment and laboratory instrument qualification, computerized system validation (CSV/CSA), data integrity, quality management and quality assurance. Learn more about our professional backgrounds and project experience on our About us page.
We work on projects in German and English. This includes both project communication and documentation.
Both are possible: for example, a document review, a qualification plan or agreed tasks across several project stages. To assess availability, we need your preferred start date, the duration and the time commitment required.
You will have designated specialists and a dedicated main contact. We agree how tasks will be divided within the team before you engage us. If one person needs to cover the entire scope, we take this into account when assessing staffing and availability.
Yes. We can use your hardware and the system access you provide. Before the project starts, we agree the equipment and access permissions required.
Yes. Where your project requires it, we work on site directly with your team. This supports short communication paths and flexible collaboration. Remote and hybrid collaboration is also possible across borders. In the initial discussion, we agree the location and on-site stages based on project needs and our availability.
You can engage QMVP under a service contract (Dienstleistungsvertrag) or a contract for work (Werkvertrag). We agree the appropriate contract type with you based on the task and the agreed services. We do not offer temporary agency staffing (Arbeitnehmerüberlassung).
Depending on the assignment, we bill for time spent at hourly or daily rates, or based on agreed work packages or milestones. We agree the billing model, scope of services and terms together before you engage us.
A brief project description and your preferred start date are enough for an initial inquiry. In the first discussion, we clarify the tasks, scope and schedule. You then receive a proposal setting out the services, fees and planned project start. Once you engage us, we begin as agreed.
Yes. The initial discussion is free of charge and without obligation. We discuss your task, the project status and how QMVP could support you. You then decide whether you would like a proposal.
Can't find your question?
Ask us directlyDiscuss your project
Direct contact
Frankfurter Straße 56
