- Full-compliance with local and global regulations;
- Obtaining Import Licenses and necessary approvals for controlled drugs;
- Security labelling and sealing;
- Specially equipped separated storage areas;
- Double-security transportation;
- Issuing certificate of destruction;
- Full tracking and inventory management in COREX Warehouse Management System (WMS).
Logistics of Controlled Drugs is a complicated process, which can be impacted by hidden pitfalls and unstructured regulatory landscape (for more information on Russia see our white-paper “Avoiding pitfalls in logistics of Controlled and Highly Active Substances in Russia”). The approach to these types of goods differs significantly from that of other pharmaceutical products and is subject to a separate set of regulations. For a depot to be allowed to handle Controlled Substances, a dedicated license and a distinctively equipped storage facility is required.
For the sponsors that are evaluating potential vendors it is paramount to understand that this process requires a very specific skill set. Failure to select a knowledgeable and reliable local partner may lead to significant delays and even failures of clinical trial execution. Both local and central depots lack practical experience in organizing importation and distribution of narcotics, psychotropic goods and highly active substances. In this respect, COREX proudly stands out, having successfully completed a large number of projects that involved both Controlled and Highly Active Substances.
COREX is one of very few local vendors that is fully licensed, has the expertise and is equipped in compliance with all applicable requirements that allows us to handle controlled drugs. We take care of the entire logistics cycle starting from obtaining regulatory approvals, utilizing sealed storage, double-security transportation and finishing with distribution and destruction.
corex process approach
- 1 CONSULTATIONS WITH THE CLIENT Creating and sharing project schedule before initiation of the project.
- 2 APPROVALS AND IMPORT LICENSES Parallel submission of the documents to appropriate authorities.
- 3 CUSTOMS CLEARANCE Conciliation of documents with customs authorities and expedited cargo release.
- 4 SPECIALIZED STORAGE Specialized storage in locked, sealed areas with reinforced doors and walls.
- 5 TRANSPORTATION Double-security transportation in sealed thermo-containers by two couriers and a security agency.