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Patient Safety and Risk Management

Stragen’s activities as a pharmaceutical laboratory are carried out within a regulated framework at every stage of a drug’s lifecycle, while adhering to latest regulatory requirements (registration, interactions with all EU health authorities, and market access) and quality standards (product compliance, monitoring, supplier and third-party quality management).

In terms of safety, our medications comply with European regulations. All of our medications are serialized and equipped with a tamper-evident system on each box. Our pharmacovigilance system continously monitor the benefit-risk balance of our medications meeting national and European regulatory requirements.

Certification DKMA

How to report a pharmacovigilance case?

For all adverse event suspicion or a security issue of one of our products, please follow the reporting pharmacovigilance procedure indicated below:

Please contact our pharmacovigilance department at :

  • Phone : +45 48 10 88 10
  • Email: info@stragen.dk

Pharmacovigilance is vital in guarenteeing the safety of medical products. Reportings are essential to ensure a continuous monitoring and in improving the safety of medications. Please feel free to contact our pharmacovigilance team if you have any concerns or questions.