Scientific Advice
Expert guidance for regulatory authority interactions
Scientific advice procedures play a central role in the drug approval process. Our experienced consultants help you interact with all relevant health authorities.
Types of scientific advice
An essential step in the early stages of developing a potential medicinal product is the preparation of the Clinical Trial Application for the First in Human (FIH) clinical trial.
QbD Group's experts will guide you through this process and subsequent steps, for example ensuring compliance with EU Pediatric Regulation Requirements, leveraging opportunities for Orphan Drug Status, and actively seeking regulatory authority input through Scientific Advice procedures throughout the development journey.
How we support you
We offer a range of specialized services to support your interactions with regulatory authorities.
Initiate authority contact
We assist in establishing initial contact with regulatory authorities, ensuring clear communication.
Prepare briefing packages
Our team prepares comprehensive briefing packages to support regulatory submissions.
Moderate authority meetings
We efficiently manage and moderate meetings with regulatory authorities.
Dossier (CMC) guidance
We provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) dossiers.
What does it entail?
Why QbD Group
Your trusted partner
Choosing QbD means partnering with a trusted leader in Regulatory Affairs.
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 Group operates globally, with QbD Austria having a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.