Laying the right groundwork so that regulatory processes can be managed efficiently — and establishing structures that provide long-term support for business objectives, growth, and competitiveness.

Diapharm makes you better.

Ein Mann im Anzug hält eine Präsentation für zwei weitere Personen und nutzt dabei ein Flipchart mit Stichpunkten zu Import- und Lagerprozessen.

Quality management that really works. Lean. Compliant. Built for business.

In the highly regulated world of healthcare products, quality management (QM) is a must. But many of the QM systems out there are overloaded, costly  — and more of a burden than a benefit.

A smartly designed QM system does more than meet regulatory requirements — it runs reliably in the background, safeguards product quality and provides maximum planning certainty. What begins as a regulatory obligation becomes a strategic tool for long-term business success.

Diapharm knows what regulators require and what companies really need. Whether you need structures for wholesale, import, or pharmacovigilance, we can distinguish between must-haves and nice-to-haves — and build systems that stand the test of time. 

Get in touch!

We are experts in developing the structure of a product. Proven. 

30
authority inspections

have been supported by Diapharm over the past three years.

We know that matters. 

140
wholesale distribution authorizations

have been obtained by Diapharm since 2015.

We know what we are doing.

134
audits

were conducted by Diapharm in 2024.

We understand quality and safety.

Diapharm stands for professionalism, expertise, and a genuine commitment to supporting clients in all aspects of pharmaceutical quality.“

Nick Lobb
Head of Quality Europe
Current client

Quality Management  

The right structures give companies stability.

Video-Datei

Diapharm knows how effective quality management systems can ensure long-term business success. Dr. Thilo Sandner and Dr. Sofia Ortlepp share their insights.

What makes the difference? 

 

A quality management system that works  —  lean, efficient and built to last. 

You need solutions that are both secure and economically sound. We balance technical precision with entrepreneurial thinking.  

You want to plan ahead and implement quality measures with confidence. We bring clarity and ultimate predictability.  

You need a system that supports your operations instead of slowing them down. We design for seamless integration. 

You want efficient, seamless collaboration with the authorities. We know exactly what they require and we’ll handle the communication for you.

 


 

So how does Diapharm make your system efficient?

 

Reviewing & Optimizing Existing Systems 
We pinpoint weak spots and align your system with what truly counts. We support pharmaceutical and healthcare companies in analyzing existing quality management structures or pharmacovigilance processes, and we know what it takes to optimize them. 

 


 

Developing Customized QM Systems 
Customized for your business—effective, robust, and built for day-to-day reliability.  We design your quality management system exactly the way you need it—practical, efficient, and audit-proof. 

 


 

Efficient Maintenance & Operations 
We take on regulatory roles, keep your system running long-term and ensure seamless operations. As an external Qualified Person, Wholesale Responsible Person, or Head of Quality Assurance, we take responsibility for your system. The QM system is audit-proof and works efficiently without tying up internal resources. 

 

More about Quality Management Systems

More about Pharmacovigilance Systems

Wondering what the optimal structures for your company should look like? We’ll show you.

Herr Dr. Middeler
Video-Datei

Diapharm means Dialogue

The Diapharm Philosophy

We listen, and we understand. We advise you and implement what you need. Together, we’ll achieve your goals, even if it means thinking outside the box.

Learn more
 

Frequently Asked Questions

What opportunities does Diapharm offer?

Verschiedene Medikamente wie Tabletten, Kapseln, Fläschchen und ein farbiger Wochendosierer auf hellblauem Hintergrund.
Verschiedene Medikamente wie Tabletten, Kapseln, Fläschchen und ein farbiger Wochendosierer auf hellblauem Hintergrund.
Quality Management (GxP)

How does Diapharm ensure GxP compliance?

Diapharm implements quality management systems, assumes AMG functions, and manages communication with authorities.
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Verschiedene Medikamente, Kräuter und medizinische Utensilien flach auf hellblauem Hintergrund arrangiert.
Verschiedene Medikamente, Kräuter und medizinische Utensilien flach auf hellblauem Hintergrund arrangiert.
Taking Responsibility

Can we use Diapharm’s quality management system?

Yes, Diapharm has both a GMP-compliant quality management system and an ISO 13485-compliant quality management system.
Learn more Learn more
Verschiedene Medikamente wie Tabletten, Kapseln, Fläschchen und ein farbiger Wochendosierer auf hellblauem Hintergrund.
Verschiedene Medikamente wie Tabletten, Kapseln, Fläschchen und ein farbiger Wochendosierer auf hellblauem Hintergrund.
Pharmacovigilance

What pharmacovigilance responsibilities does Diapharm assume?

Diapharm assumes all regulatory functions: the EU QPPV and national QPPVs for the DACH and Benelux regions.
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Areas of Consulting Expertise

Expertise across multiple disciplines.

Drei Personen im Gespräch an einem Tisch mit Laptop und Whiteboard im modernen Büro.
Drei Personen im Gespräch an einem Tisch mit Laptop und Whiteboard im modernen Büro.
Understanding Markets

How to position yourself perfectly for market entry.

Understand requirements, hurdles, and opportunities to strategically shape market access.
Learn more Learn more
Verschiedene Medikamente, Kräuter und medizinische Utensilien flach auf hellblauem Hintergrund arrangiert.
Verschiedene Medikamente, Kräuter und medizinische Utensilien flach auf hellblauem Hintergrund arrangiert.
Designing Innovations

Develop products and bring them to market successfully.

Creative products. Smart design. Pragmatic go-to-market strategies. And real impact in the marketplace.
Learn more Learn more

You’d like to know more about how to design QM systems? Let’s chat!

Sprechen Sie mit uns!

“What is Diapharm particularly good at? Translating structures into clear, actionable practice.”

Dagmar Siebert
Managing Director
089PHARM GmbH

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