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Early Development - Regulatory Affairs - QbD Group

Early Development

Early development is a critical phase in bringing a medicinal product to market.

At QbD Group, we specialize in guiding you through this process, ensuring compliance with regulatory standards and leveraging key opportunities such as Orphan Drug Designation and Pediatric Investigation Plans. Our expertise ensures a smooth and efficient development journey from start to finish.

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What is 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 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. 

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. Here's how we can help:

  • Early-phase development  
  • Clinical Study applications (CTA, Protocol, IB, IMPD)
  • Orphan drug designations (ODD) 
  • Pediatric investigation plans (PIPs) 
  • PRIME 
  • Scientific advice
How can we support
PMS - Regulatory Affairs - QbD Group (2)

 

How we support you

We provide seamless assistance in preparing essential documentation and navigating regulatory requirements for your clinical development journey. From trial applications to special designations, our expertise ensures your path to success is smooth and well-supported.

First-in-human clinical trial application

We assist in the preparation and submission of FIH trial applications, ensuring compliance with regulatory requirements and supporting a smooth transition into clinical testing.

Documentation preparation

Our team ensures the accuracy, completeness, and compliance of all necessary documentation, including Clinical Trial Applications (CTAs) and Investigational Medicinal Product Dossiers (IMPDs).

Orphan drug & Pediatric plans

We support efforts to obtain Orphan Drug Designation and develop Pediatric Investigation Plans, providing the necessary expertise to navigate these specialized regulatory pathways.

PRIME applications & scientific advice

We offer expert guidance for PRIME applications and scientific advice, helping to accelerate the development process and meet evolving regulatory expectations.
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Why partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​ 

Choosing QbD means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.

  • 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, at QbD Austria with a special focus on Europe (EU) and China.​
  • Customer satisfaction​: constant evaluation, transparency and clear objectives.​ 
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Have questions about your early development process?

Reach out to our experts for tailored support and guidance. We’re here to help you navigate every step of your journey from Clinical Trial Applications to regulatory compliance.

Contact us today to get started!







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