Early Development
Navigating the early stages of drug development
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 clinical trial.
What is early development?
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 provide seamless assistance in preparing essential documentation and navigating regulatory requirements for your clinical development journey.
First-in-human clinical trial application
We assist in the preparation and submission of FIH trial applications, ensuring compliance with regulatory requirements.
Documentation preparation
Our team ensures the accuracy, completeness, and compliance of all necessary documentation, including CTAs and IMPDs.
Orphan drug & Pediatric plans
We support efforts to obtain Orphan Drug Designation and develop Pediatric Investigation Plans.
PRIME applications & scientific advice
We offer expert guidance for PRIME applications and scientific advice, helping to accelerate the development process.
Early development strategies
Navigating the early stages of drug development is critical to setting a strong foundation for success. Our tailored strategies ensure your project meets regulatory expectations while maximizing efficiency and innovation.
Early-phase development
Comprehensive support for the earliest phases of your drug development programme.
Clinical Study applications
CTA, Protocol, IB, IMPD preparation and submission.
Orphan drug designations
Support for obtaining Orphan Drug Designation (ODD).
Pediatric investigation plans
Compliance with EU Pediatric Regulation requirements.
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.