All operations related to the management of Investigational Medicinal Products are carried out under the responsibility and control of the Qualified Person.
Purchase of products
Research and purchase (sourcing) of products required for the conduct of your clinical trial: Investigational Medicinal Products, comparators, related products
Import authorisations
Labelling and Secondary Packaging
Design of patient kits
Elaboration of label models and master production file
Packaging at required temperature (ambient, refrigerated, dry ice…)
Blinding operations and effective blinding verification tests
Retention sampling according to the regulations in force
Certification by the Quality Person (QP)
Storage and distribution
Storage at required temperatures according to ICH standards (+ 15 / + 25 ° C, + 2 / + 8 ° C,
-30 ° C and -80 ° C)
Monitoring of expiry dates using an automatic system for renewal of supplies or manually upon request
Dispensation to investigation sites generated automatically, upon request or in emergency
Control of the supply chain at all temperatures, traceability of temperatures during transport
Certified Return, Recall and Destruction
Product return at Client’s request, verification and registration
Management of batch recall in collaboration with the Client
Destruction by incineration and issuance of a destruction certificate
Regulatory Procedures
Liaison with Health Authorities
Regulatory Watch
Audits of pharmaceutical service providers on behalf of Clients