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