Agency Interactions
Sucessfully submit your application for drug approval to the competent authorities.
At QbD Austria we help you to interact with the required health agencies.
Preparation and communication
Agency interactions play a central role in the drug approval process. For example, in the European Union (EU), a company that wishes to bring a pharmaceutical to the market must submit an application to the competent authority or the European Medicines Agency (EMEA) for a ‘marketing authorisation’ (licence).
In case of the Centralised Procedure an application is made to the EMEA. For all other procedures – National, Mutual Recognition Procedure (MRP) and/or a Decentralised Procedure (DCP) – an application must be made to the national competent authority(ies).
Our team of experienced consultants help you to interact with all relevant health authorities.
How we support you
- Initiate contact with the relevant authorities
- Prepare briefing packages
- Moderate authority meetings
- Dossier (CMC) guidance
Why opt for the QbD Group?
EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
10+ years of experience
Benefit from our team of highly qualified consultants.
Full life cycle support
Full support from pre- to the post-marketing phase.
Global presence
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction
Constant evaluation, transparency and clear objectives.
Contact us
Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.