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Quality Management

Diapharm is a full-service provider for all aspects of quality assurance, quality control and quality management in the pharmceutical industry – for medicinal products, medical devices, and borderline products.

Do you, as a pharmaceutical company, want to release a medical device on the market, however you need the required QM system?

Are you looking for someone who will assume the responsibility for your medicinal products and medical devices?

We advise you on all questions relating to every aspect of analytics, batch release, QP services, QM systems and audits / inspections.

Your benefits

  • Relief of responsibility for legal functions
  • Cost savings from pooled projects
  • Goal- and demand-oriented GMP support

Our services relating to quality management:


Analytics

We advise and support you in all aspects of analytics. We develop analytical methods and conduct analytical method validations at our own laboratory. We also assist you with pharmaceutical quality control.

Batch release

We hold the appropriate manufacturing authorisation and can assume all batch release responsibilities as defined by EU for medicinal products and medical devices.

QP services
We assume responsibility for the functions stipulated by EU regulations for medicinal products and medical devices.


QM systems

We offer GMP-compliant quality management systems for medicinal products and EN ISO 13485 for medical devices, and we would be happy to advise you about quality assurance practices in the pharmaceutical and medical devices industry.


Audits and inspections

We travel worldwide to audit and qualify your suppliers for you. Cost savings from pooling and sharing are diverted directly to you.

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