Comparators sourcing
Creapharm, can help you in your clinical trials management by offering you a service of comparators sourcing.
Thanks to an international network of wholesalers, we will do our upmost to satisfy your needs by providing you :
- a unique batch number when possible,
- a long expiry date to avoid relabelling.
Importation and pharmaceutical release in Europe of IMP.
We can handle the importation, customs clearance, storage, distribution, returns of IMP (drugs) directly or by our worldwide depots network.
A dedicated project manager provides each client with a tailored management and service of the highest quality in compliance with American and European Guidelines and Directives.
The European medical agency EMEA requires IMP batches used in trials performed in any EU country to be released by an EU Qualified Person. The release may be done by the clients QPs or by the contractor's QP.
Creapharm's Qualified Persons routinely release batches produced and/or packed and/or distributed by Creapharm in accordance with its clients when they so require.
We can also provide this service for medicinal products produced in non EU countries which need to be imported either as bulk to be labelled and packed or as finished clinical products to be distributed to investigation centers.
The process may be more or less extensive depending whether the products is produced in a country with EMEA recognition ( example Switzerland and Canada) or not (example United States).
For countries with mutual recognition the standard release is based on documentation and on the batch record released by a local QP. For other countries the standard release is backed by additional evaluations.
Creapharm will be capable of managing importation and European release.
Our services may include:
technical review of the documentation,
audit of the manufacturers (drug substance and drug product),
quality control of the drug product,
supply of the QP release certificate. | 
