Bridging your regulatory needs to pharma solutions

  • Regulatory affairs

    For companies in the healthcare and pharmaceutical sector
  • Pharmacovigilance

    Monitoring of your products’ safety profile as well as medical literature for identifying potential adverse reactions
  • Information

    Timely information on all new requirements and updates in medicinal products legislation and pharmacovigilance amendments
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Medical device notification services

We provide comprehensive local advice, preparation and submission of medical device notifications.
Should you wish to apply for reimbursement of your medical device and if it is subject to reimbursement we will prepare and submit the necessary documents for obtaining reimbursement status as well.

As part of this service we also prepare translation and adaptation of your labeling and leaflet text so that it complies with the latest requirements. Of course we can also evaluate your text and advice on its suitability.