Acting as your Marketing Authorisation Applicant in the EU
DLRC Pharma Services can act as the Marketing Authorisation applicant/holder for non-EU based sponsors.
The Marketing Authorisation applicant/holder must be a legal entity established in the EU.
DLRC Pharma Services – Helping you to obtain Marketing Authorisation without a presence in the EU
DLRC Pharma Services can act as the Marketing Authorisation (MA) applicant/holder for non-EU based sponsors.
We have experience of successfully managing national, decentralised, mutual recognition and centralised procedures. DLRC Pharma Services has the systems and processes in place to take on the role of Applicant quickly and effectively.
- An interim solution – perfect for non-EU sponsors seeking to out-licence rights to a partner company without delaying gaining EU regulatory approvals
- Avoid the need to set up and maintain an EU legal entity (including complying with PV requirements) when following an out-licence model
- Facilitate obtaining MAs in additional markets that may be required to implement commercial strategies
- A straightforward fee structure