- Obtaining Import License for Investigational medical product (IMP);
- Issuing necessary certificates for medical devices and clinical trial materials (CTM);
- Named Patient Program support;
- Obtaining Export License for bio-samples;
- Controlled Drugs importation and handling;
- Any additional approvals and permissions.
The majority of clinical trial supplies are subject to specialized non-tariff regulations for unregistered investigational drugs, accompanying clinical trial materials and medical devices in which one must obtain obligatory permissions from the relevant governmental authorities. The situation with import/export regulations differs from country to country. For example, Russian authorities require only one license for the entire project; Ukrainian authorities require one license for the study and one for each bulk shipment; in Georgia, depending on the type of goods, the import license may not be required at all. This is where our local presence and expertise become invaluable.
Continuous experience in working on some very specific imports/exports for clinical trials (cryptographic devices, hazardous materials, bio-samples, controlled drugs, etc) and an intricate system of SOPs allows COREX to avoid potential risks that may arise when issuing a license or preparing a letter of exemption.
We remove the burden of regulatory processes from our customers by offering submission of necessary documents for official approval of a study drug / CTM importation. COREX regulatory managers are always in constant close contact with the regulatory representatives and are well-informed about any upcoming changes in local legislation. COREX team collects all pertinent documents, double-verifies its completeness and accuracy and guarantees approval within 10 working days.
corex process approach
- 1 REGULATORY FEASIBILITY Gathering trial-related information and product specifications.
- 2 CONSULTATIONS WITH LOCAL AUTHORITIES Detailed consultations with regulatory representatives and dossier composition negotiations.
- 3 PREPARATION OF DOCUMENTS Preparation of necessary documents, double-verification of data completeness and accuracy.
- 4 EXPEDITED SUBMISSIONS Same day submissions to the Ministry Of Health (MoH) or other designated regulatory body.
- 5 ISSUING NECESSARY APPROVALS Monitoring submission status and just-in-time receipt of the originals.