Our regulatory affairs professionals have in-depth knowledge of national legislation, in addition to extensive clinical trials expertise in working with regulatory agencies (RA) and ethics committees (EC) in multiple jurisdictions within Eastern Europe (e.g. Czech Republic, Hungary, Latvia, Lithuania, Estonia, Poland, etc.) and ex-USSR (e.g. Belarus, Georgia, Russia, Ukraine, Moldova, Armenia, Kazakhstan, Uzbekistan). We are committed to diligent preparation of all documents for RA and EC submission and we make sure that regulatory approval procedures managed by our team run smoothly and without delays.

We provide the following services:

  • Compilation of initial submissions, amendments, notifications, and closeout submissions to RA and ECs
  • Customization/review of informed consent documentation
  • Negotiation with insurance companies on compulsory trial subjects' insurance
  • Comprehensive regulatory support throughout the study
  • Obtaining of import/export licenses for the study drug and biosamples
  • Regional regulatory consultation

If you are interested in regulatory submission services provided by Cromos Pharma, please feel free to contact us.