Regulatory Support

Regulatory Support

 

Regulatory support is the key to rapid regulatory approval.

Atlant Clinical always keeps an eye on ultimate regulatory approval through scrupulous preparation and multilevel study review. We have extensive experience working directly with regulatory authorities and continually track documents throughout the approval process to ensure efficient project management, leading to fast approval at minimal cost.

We handle:

  • preparation and submission of trial dossier to regulatory authorities
  • procurement of import and export licenses for study drugs and all other necessary supplies
  • safety reporting, in accordance with ICH GCP and local regulations
  • timely submission of all study-specific documents to Ethics Committees and/or regulatory authorities, in accordance with ICH GCP requirements and local regulations