Comparator Sourcing and IMP Importation and Pharmaceutical Release in Europe

Comparator Sourcing
Thanks to an international network of partners Creapharm is able to satisfy your needs of comparator sourcing by providing you:

– A unique batch number when possible,
– An expiry date as long as possible to avoid clinical relabelling.

IMP Importation and Pharmaceutical Release in Europe
Creapharm has the authorization to import, to store, to distribute and to organize the returns of IMP (drugs) directly or by its worldwide depots network.

A dedicated project manager provides each client with a customized management and service of the highest quality in compliance with American and European Guidelines and Directives.

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.
This service is also available for medicinal products produced in non EU countries which need to be imported either as bulk (before clinical labelling and packaging operations) or as finished clinical products (before clinical distribution to investigation centers).

The process may be more or less extensive depending whether the products are produced in a country with EMEA recognition or not.

– 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 importation and pharmaceutical release 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.

For more information or to discuss comparator sourcing and IMP importation and pharmaceutical release in Europe please contact us directly.