Orphan Diseases
Supporting the development of medicines for rare diseases
Orphan diseases are conditions that affect a small percentage of the population. QbD Group can support you in the development of medicines for patients suffering from rare diseases.
What are orphan diseases?
Orphan diseases, also known as rare diseases, are conditions that affect a small percentage of the population.
Despite their rarity, there are over 7,000 identified orphan diseases, collectively impacting millions of people worldwide. These conditions often lack effective treatments due to limited commercial interest, making the development of orphan drugs vital for improving patients' quality of life.
To encourage innovation in this area, regulatory agencies like the European Medicines Agency (EMA) offer the Orphan Drug Designation (ODD), providing pharmaceutical companies with incentives such as:
• Extended market exclusivity
• Reduced regulatory fees
• Specialized scientific guidance through protocol assistance
QbD Group is here to help you navigate the complexities of orphan drug development, ensuring that your efforts lead to impactful treatments for patients in need.
How we support you
At QbD Group, we offer end-to-end support for Orphan Drug Designation (ODD) applications and ongoing compliance, helping you bring innovative treatments to patients with rare diseases.
Expert ODD application support
We assist with every stage of the ODD application process, including preparing submissions, conducting pre-submission meetings, and addressing questions or oral explanations during the procedure.
Compliance beyond designation
Our team ensures you meet all obligations post-designation, such as preparing annual reports and maintaining ODD status during the marketing authorization process.
Tailored guidance
With our deep regulatory expertise, we provide customized strategies to maximize incentives like market exclusivity, reduced fees, and access to protocol assistance.
Why QbD Group
Your trusted partner
Choosing QbD Group 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, 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.