Early Development
An essential step in the early stages of developing a potential medicinal product of a candidate medicinal product is the preparation of the Clinical Trial Application for the First in Human (FIH) clinical trial.
Qbd’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.
Early Development Strategies
- Early-phase development Â
- Clinical Study applications (CTA, Protocol, IB, IMPD)
- Orphan drug designations (ODD)Â
- Pediatric investigation plans (PIPs)Â
- PRIMEÂ
- Scientific advice
How we support you
- We provide assistance in the preparation of the first-in-human (FIH) clinical trial application.
- We assist in the preparation of all necessary documentation, from CTAs to IMPDs, ensuring accuracy, completeness, and compliance with regulatory standards.
- We support efforts to obtain Orphan Drug Designation (ODD) and Pediatric Investigation Plans (PIP).
- Additionally, we provide expert scientific advice and support for PRIME applications.
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.
