Regulatory submission and contracting

We maintain a database of timelines and country-specific flowcharts of regulatory procedures in most European countries. Local experts prepare the dossier and follow-up the submission process and mediate the communication between the regulatory bodies and the Sponsor.

In parallel with the regulatory procedures, the PM initiates the negotiations of contracts with vendors:

  • Contracting investigators and hospitals
  • Contracting central labs and other relevant vendors
  • Contracting drug distribution companies and pharmacies

Regulatory process in Czech Republic


Regulatory process in Czech republic

Regulatory process in Slovakia

Regulatory process in Slovakia

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