Simbec-Orion is delighted to share that as part of our ongoing strategy to provide full support and services to our clients, we have established an entity in the Netherlands through which we are able to import IMP into the EU, QP certify, and then release for use within clinical trial sites across the EU/EEA. This service is provided as part of our wider clinical trial management support for studies conducted by Simbec-Orion but can also be delivered as a bespoke standalone service.
Most importantly, this capability includes direct-to-site import of radiopharmaceutical IMP to EU hospital sites for oncology trials, as well as the importation of a range of IMP for all study types including:
- Sterile products
- Non-sterile products
- Biological medicinal products
- Immunological products
- Biotechnology products
We hold a Manufacturers/Importers Authorisation for Investigational Medicinal Products (MIA(IMP)) and have experienced QPs and a dedicated Quality team ready to support your study. We partner with a Netherlands-based GMDP licenced facility for the physical importation of IMP, as well as storage and distribution.
We are excited to offer this as a flexible, responsive, customer focussed option for our clients and we would be happy to connect you with our IMP Management team to discuss how we can support your next clinical trial.