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

Across Alliance
This time, we are going to New England!Meet us in November at Outsourcing in Clinical Trials in Boston, MA. 
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