Scientific Advice
Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Firstly, it ensures alignment with regulatory requirements, enhancing the likelihood of successful approval. Additionally, it facilitates early identification and resolution of potential regulatory hurdles, saving time and resources.
Provide scientific advice, both internationally (EMA, FDA) and nationally by reviewing national procedures. Our highly skilled QbD Experts can guide your project teams, write high-quality briefing books and help you prepare for the meetings with EMA, FDA, or national agencies or attend them on the client’s behalf.
At QbD, we assist you in interacting with necessary health agencies by guiding you through scientific advice and protocol assistance with EMA, FDA, and national agencies, as well as pre-submission meetings.
Agency Interactions
Successfully submit your application for drug approval to the competent authorities. Qbd we help you interact with the required agencies.
Preparation & CommunicationÂ
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 (EMA) for a ‘marketing authorization’ (license).Â
Depending on the procedure, our team of experienced consultants help you to interact with all relevant health authorities:Â
- Centralized procedure: interaction with EMA, (co)-rapporteur, concerned member state.Â
- National, Mutual Recognition Procedure (MRP) and/or a Decentralized Procedure (DCP): interaction with national agencies.
How we support you
- Initiate contact with the relevant authorities .
- Prepare briefing packages.
- Moderate authority meetings.
- Dossier (CMC) guidance.
Why QbD Group?
Benefit from our team of highly qualified consultants. ​
Full support from pre- to the post-marketing phase.​
QbD Group operates on a global scale, with offices strategically located across Europe and South America. This extensive network allows us to efficiently execute projects in diverse locations worldwide.
Constant evaluation, transparency and clear objectives.​
Contact us
Contact us for more information or to request a free, no-obligation proposal.
