Services since 1998
EU-FDA MRA and Brexit compliant
Marketing authorisation holding
European marketing authorizations (MA’s) for medicinal products can only be held by European legal entities. We hold such authorizations for non-EU pharmaceutical companies which, for various reasons, do not (yet) have established such EU legal entity. For European companies we can held duplex authorizations, i.e. a copy of the original MA, which subsequently may be transferred to yet other pharmaceutical companies. This service includes the responsibilities related to MA’s such as pharmacovigilance and lifecycle variation support.
Pharmaceutical manufacturing & importation
(Veterinary) pharmaceutical products manufactured outside the EU may only be imported into the EU by an EU legal entity which holds a manufacturing & importation license as issued by the competent autority of an EU member state. We serve as such site of importation for various clients and we have developed various supply and finance models to meet the needs of the usually different situations of these clients. This service includes logistic support to transfer your products from your site of establishment to our warehouses via air or seatransport.
Investigational gentherapy products
Quite recently we obtained a license for the importation of investigational gentherapy products (iGTMP). This license aims to support a USA company with respect to the European part of their clinical study including such product based on a adeno-associated virus (AAV) vector.
API's and narcotics
For the importation and wholesale of active pharmaceutical ingredients (API's) within the EU, an API-distribution license is required. We hold this license and act as the distributor on behalf of various clients.
Narcotics are subject to the most stringent EU regulations and require separate highly protected storage locations as well as (separate) narcotics and cannabis licenses. In addition, all trans-actions and stocks alterations need registration and notification to the competent authority. We have required experience to deal with narcotics or cannabinoids and may support your EU distribution of these kinds of products.