Submissions

Irrespective of the type of your regulatory procedure your applications for marketing authorisation must be accompanied correctly by the required documentation.

QbD Group will help you to get your documents right.

Types of applications in the EU

Navigating the regulatory landscape for marketing authorization can be complex, with strict requirements for documentation and compliance. Whether you're preparing a complete application for an original product, an abridged application for a generic, or submitting a dossier for a fixed combination product, precision is key.

At QbD Group, we specialize in helping you get your submissions right the first time. With our expertise, we ensure your applications meet all regulatory standards, saving you time and effort.

Explore the types of applications in the EU and how we support each one:

Complete/full applications: comprehensive dossiers for original products.
Abridged applications: streamlined submissions for generics.
Fixed combination products: tailored support for unique medicinal combinations.

Complete and independent applications (original products)

For complete applications the MA must be accompanied by the particulars and documents set out in article 8 of directive 2001/83/EC, including:

Physio-chemical, biological or microbiological tests
Pharmacological and toxocological tests
Clinical trials

Abridged applications (generics)

These are either with informed consent form the originator or essentially similar to a product authorised for 6 to 10 years (10 years according to the new regulation) – Generic application.
The applicant is NOT required to provide the results of pharmacological and toxicological tests or the results of the clinical trials if the application is abridged. Abridged applications refer to information that is contained in the dossier of another “original” authorisation.
This information is NOT completely available in the public domain.
Generic and Informed consent applications are thus linked to the original product.

Application for a fixed combination product

Strictly speaking, any fixed combination is a new and unique medicinal product requiring a separate Marketing Authorisation and SmPC.
It can be considered as a complete/full independent application.
Generic /Informed consent applications referring to fixed combination dossiers are acceptable.

Application for a fixed combination product

How we support you

Our expert team provides comprehensive support for your regulatory needs, ensuring your submissions meet the highest standards of quality and compliance.

Dossier content & structure advice

Perform gap analysis

Compile technical dossiers

Application packages ready for submission to EU authorities

Why partner with 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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