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