The service organisation for the health industry
The one-stop contractor in clinical research

Welcome at the website of MediServ

REGULATORY AFFAIRS

MediServ is founded in 1980 in principle as an organization for regulatory affairs. In 1982 we started with the first clinical trials, but the registration services are maintained till today.

For registration we are specialised in applications in Belgium, Luxembourg and the Netherlands. For the Netherlands MediServ co-operates, when necessary, with Baggerman Farma Consult, Eindhoven. Additionally we have access to regulatory affairs in other European countries, such as Spain, France, Scandinavia and the United Kingdom. Since 1980 MediServ has been actively involved in about 200 registration dossiers and over 500 submissions of special issues (for instance related to new regulations). The clients have come from 181 pharmaceutical companies from 11 nations in the European Union and the United States of America.

The services include:

  • Complete registration dossiers for application
  • Special assignments (TSE etc.)
  • Production or evaluation of expert reports
  • Production or evaluation of the Summary of Product Characteristics
  • Production or evaluation of the Patient Information Sheet
  • Production or evaluation of package labels.

    We are available for preparation of and/or presence on hearings of registration committees.

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