EU GMP regulations require that Drug Product manufactured outside the EU must be imported to a site which has the appropriate licence.
The Cilatus Manufacturing Services licence enables us, if the client desires, to qualify, elect and contract with a logistics and warehousing company to facilitate importation of drug product into the European Union.
The team’s detailed knowledge of Good Distribution Practice requirements (EU Guideline 2013/C 343/01) ensures we can provide our clients with advice and guidance in relation to the most appropriate supply chain and distribution model. We can add clients products to our licences, leading to efficiency and cost benefits.
As per the Good Distribution Practice Guidelines our expert team can act as Responsible Person on behalf of our clients if required.