Regulatory affairs

Up to date with laws and regulations

Before your study can start, there are legal and regulatory requirements to be observed: Depending on whether your product is in the development phase or already on the market and whether it is a medicinal product or a medical device, different application and approval procedures are required. In most cases, the study must be approved by the Competent Authority and an Ethics Committee.

Our team of experts will handle the entire application process on national and European level.

We stand for highest quality in regulatory submission and compliance with all timelines during this crucial step before the start of your study.

Regulatory affairs

  • Regulatory classification of your study
  • Support of study sites regarding required documents
  • Compilation of application dossiers
  • Conduction of the submission (CTIS for clinical trials with drugs, DMIDS for clinical investigations with medical devices, EthikPool)
  • Answering inquiries and communicating with authorities and ethics committees
  • Submission of subsequent amendments
  • Submission of final reports

Winicker Norimed GmbH

Deutschherrnstraße 15-19

90429 Nuremberg

Phone: +49 (0) 911 / 9 26 80 – 0


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