Orphan Diseases

QbD Group can support you in the development of medicines for patients suffering from rare diseases. Orphan drug designation (ODD) in Europe provides a number of incentives for pharmaceutical companies including prolonged market exclusivity, reduced agency fees, and access to protocol assistance.

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, and
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.

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?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

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, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.

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Looking for expert support in Orphan Drug Designation (ODD) for rare diseases?

Reach out to us and our experienced team will guide you through the entire process, from application to maintaining ODD compliance.

Orphan Diseases

What are orphan diseases?

How we support you

Expert ODD application support

Expert ODD application support

Compliance beyond designation

Compliance beyond designation

Tailored guidance

Tailored guidance

Why QbD Group?

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