Regulatory escort of cargo

Compliant and timely supplies of Investigational Medicinal Products, Clinical trial materials, Devices and samples are critical element of each and every start-up and may influence timelines of Site Initiation Visits (SIV). We proactively review list of products and consult our partners on the requirements and scenarios for importation.

In case product specifications are not availabile prior to study activation our dedicated team is able to review and provide the scheme of importation within 24 hours from the request.

Our local expertise lays within:

Import License Submission for Investigational Medicinal Products;
Import License Submission for Expanded Access Programs;
Import License Submission for Importation of Samples For Registration;
Export License Submission for Exportation of Biological Samples;
Obtaining Declarations of Confortmity, Registration Certificates for Medical Devices;
Obtaining FSB Notification for Cryptographic purposes;
Importation of unregistered medical devices under the letter of guarantee;

As a part of our service we assist our partners in:

Treatment kit design;
Label proof preparation and translation;
Booking of airfreight to/from customs;