What we do

Regulatory Affairs

We are local experts, we pave the way

In an increasingly regulated, complex and changing environment, a sound regulatory approval strategy is paramount to any trial’s success. Our staff are local experts in the culture and expectations of the regions, and this, paired with a broad therapeutic and regulatory experience, allows to accelerate trial approval.

Our service offerings:

  • IMPDs
  • Strategic regulatory plans
  • Clinical trial applications
  • Competent authority submissions
  • Ethics committees submissions
  • Voluntary harmonisation procedure submissions
  • Clinical trial agreements
  • IMP labels
  • Import and export licenses
  • EU legal representations
  • Translations
  • Patient insurance expeditions
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