With our excellent knowledge of regional law and regulatory requirements, ACLIRES can support and guide you through all the necessary regulatory steps to guarantee the smooth approval of your project and fast drug importation:
  • Consulting for regulatory requirements
  • Preparation and back translation of ICF
  • Preparation of submission documents for IRBs/IECs
  • Drug importation: preparation and application of import license of IMPs
  • Preparation and coordination of responses to FDA requests for information.
  • Preparation and submission of amendments, safety report and annual reports
  • Application for medical device import
  • Pharmacovigilance reporting
  • Advice and review on labeling requirement for IMPs