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Our Services and Solutions
Do you feel lost and overwhelmed in the "Regulatory Jungle" of today's evolving and regulated healthcare system, driven by emerging technologies?  

Let us help you to implement Quality & Regulatory Compliance
and achieve fast & cost efficient market & audit readiness for your product.

We specialize in digitalization and new technologies in regulated life science and healthcare industries. Nothing drives us more than to invent with each new experience and knowledge together with our clients, new approaches for efficient quality and compliance management with an agile and lean approach.

 

Current areas of tension, such as Artificial Intelligence, Industry 4.0, Cloud Computing, are our favorite playground where we develop scientifically based MVPs for our customers' application

 

These include: lean quality management systems, agile computer software validation and qualification, software as a medical device, combined products, digital health apps, digital therapeutics and digital health platforms, and quality & audit readiness of state-of-the-art biotech labs and production facilities.

 

May we also inspire you with our services and competencies? We are looking forward to an exchange with you.

Quality Management & Regulatory Compliance 

Data Integrity, Privacy and Information Security

Audit & Assessment Services

Agile Computer System Validation (CSV) and Software Life Cycle Management

Digital Health Solutions (SaMD, Digital Health Platforms

and more)

Business Analysis, Usability & Requirement Engineering

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Systemic Business Coaching & Change Management

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