Regulatory support is the key to rapid regulatory approval.
Thorough scrupulous preparation and multilevel review of study documents, extensive expertise in working with the regulatory authorities, and continual tracking of documents throughout the approval process, we ensure an efficient project, leading to quick approval at minimal cost.
- preparation and submission to the regulatory authorities of the trial dossier
- obtaining necessary local insurance
- obtaining import/export licenses for the study drug and any other 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 local regulations and GCP requirements