Submissions
Getting your marketing authorization right the first time
Navigating the regulatory landscape for marketing authorization can be complex, with strict requirements for documentation and compliance. We ensure your applications meet all regulatory standards.
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.
How we support you
Your applications for marketing authorisation must be accompanied correctly by the required documentation. Our expert team provides comprehensive support for your regulatory needs.
Dossier content & structure advice
Expert guidance on dossier content and structure aligned with regulatory expectations.
Perform gap analysis
Thorough gap analysis to identify and address documentation deficiencies before submission.
Compile technical dossiers
Complete compilation of technical dossiers meeting all regulatory requirements.
Application packages ready for submission
Complete application packages ready for submission to EU authorities.
Application types
Explore the types of applications in the EU and how we support each one:
Complete/full applications
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 toxicological tests, and clinical trials.
Abridged applications (generics)
Either with informed consent from the originator or essentially similar to a product authorised for 6 to 10 years. The applicant is NOT required to provide the results of pharmacological and toxicological tests or clinical trials. Generic and Informed consent applications are linked to the original product.
Fixed combination products
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.
Bibliographic applications
Support for well-established use applications.
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.