Why Qualificiency?

Radiopharma is complex. Working with the right partner should not be.

Qualificiency was founded to bring clarity, structure and practical progress to environments where compliance, performance and operational reality have to align every day.

Professionals working together at an interface

Why the user side matters

Experience is valuable when it changes how decisions are made.

We bring together radiopharma, quality, validation and operational experience, but we do not treat expertise as separate silos. We look at the whole system and involve specialist support when it materially improves the outcome.

Process before structure
Professional judgement, not procedure alone
Build capability rather than dependency
Use specialist expertise where it genuinely adds value

Our story

Experience matters most when it changes how you work.

Professionals walking through a light glass operational environment

Our team brings together decades of experience across radiopharmaceutical operations, quality, engineering, logistics and regulatory leadership.

We design from the process first. Only then follow the facility, organisation, automation, workflows and quality structure. That sequence helps create solutions that are compliant, sustainable and practical without unnecessary complexity.

Qualificiency began in 2025, when Marlous van der Hooft established her independent consultancy, bringing together her experience in radiopharmaceutical operations, GMP and organisational performance.

As the work developed and the team grew, Qualificiency evolved beyond an individual consultancy. In 2026, this development led to the formation of Qualificiency Consulting GmbH, currently in Gründung (i.G.), bringing complementary expertise together within one organisation.

The underlying approach has remained the same: connecting compliance with operational reality, strengthening professional judgement and designing processes that work in practice.

The people behind Qualificiency

Two perspectives. One connected approach.

Qualificiency brings together operational and quality leadership from the user side of radiopharma — connecting compliance, performance and the realities of day-to-day work.

Founder & CEO

Marlous van der Hooft

Radiopharma Operations & Compliance Culture

Before founding Qualificiency, Marlous spent nearly two decades at GE HealthCare in radiopharmaceutical manufacturing and operations. She managed or supported the design, build, qualification and start-up of 13 PET manufacturing sites across Europe, and later held manufacturing, site operations leadership in Braunschweig and global contract-manufacturing supply-chain roles. These experiences shaped her process-first approach: connecting Operations, Quality, Engineering and suppliers so that compliant systems also work in daily practice.

Dutch-born · based in Germany · working internationally

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Founder

Wolfgang Pitsch

Radiopharma Quality, QP & Operational Excellence

Dr. Wolfgang Pitsch brings more than two decades of radiopharmaceutical Quality and GMP experience at GE HealthCare in Braunschweig, progressing from Validation Site Leader through QA and QC leadership to Quality Operations Director / Head of Quality. His background includes Qualified Person responsibilities, batch release, radiation protection, inspections, supplier audits and pharmaceutical quality systems. With a doctorate in organic chemistry and postgraduate radiopharmacy education, he connects regulatory judgement, technical understanding and practical operational improvement.

Germany · radiopharma quality leadership · QP perspective

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Our people

Meet the team

Different backgrounds in radiopharmaceutical operations, quality, regulatory affairs and logistics. One connected approach built around practical experience and professional judgement.

Jana Schmücker

Junior Validation & Quality Specialist

Radiopharmaceutical manufacturing experience developed into validation, qualification and quality systems support.

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Martina Tiedemann

Senior Consultant | Quality, Regulatory & Product Lifecycle

Over 25 years across radiopharmaceutical quality, regulatory affairs and product lifecycle management, with a particular passion for artwork management.

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Claudia (Claudi) Kästner

Business & Operations Support | Radiopharmaceutical Logistics

Nearly 25 years in radiopharmaceutical logistics, now combining customer transport expertise with service-oriented business and team support.

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Qualificiency in Practice

Experience put to work since 2025.

Since its foundation in 2025, Qualificiency has supported radiopharmaceutical and pharmaceutical organisations with on-site supplier and CDMO audits in Europe and the United States, GMP quality-system development, qualification and validation assessments, contamination-control strategies, operational-readiness support and professional training. Across different technologies and regulatory environments, we connect regulatory expectations with the realities of processes, equipment and people.

What sets us apart

Not only what we know. How we work.

The strongest solutions combine technical depth with the ability to see the system around the technical answer.

Process-first

We design around real workflows, constraints and intended use rather than assumptions.

Holistic & practical

Strategy has to survive contact with routine operation, people and real decisions.

Integrity-led

Clear advice, transparent reasoning and ownership matter more than convenient answers.

People-focused

We help teams understand what good looks like and strengthen capability rather than dependence.

Vision

Compliance and performance should reinforce each other.

We want to help shape radiopharmaceutical and pharmaceutical operations where clarity, integrity and well-designed processes create sustainable performance.

Mission

We design, optimise and safeguard processes from a holistic, process-oriented perspective — integrating compliance into daily work while strengthening performance, culture and organisational capability.

Connected expertise

The right expertise, when it adds value.

Qualificiency works with a broad specialist network and trusted suppliers. Where a challenge needs expertise beyond our own team, we help connect the right people and coordinate the interfaces rather than pretending one discipline can solve everything.

Where Compliance meets Performance.

See how that translates into your operation.

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