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EU MARKETING AUTHORIZATION 

In Europe, pharmaceutical companies have a choice of a number of different marketing authorization routes: centralized, decentralized, mutual recognition and national marketing authorisation applications:

We can propose the best route for your particular product and marketing plan, and then assist in development and submission of the dossier to the relevant regulatory authority.

DLC can help with:

• New drug and biologic drug product applications
• Orphan drug product applications (for rare diseases and disorders)
• Applications for Paediatric Use Marketing Authorisations (PUMA)

We are also experienced in providing Common Technical Document support, including for e-CTD submissions.

In addition, DLC can assist you in setting up the Summary of Product Characteristics (SPC), label and package leaflet texts according to European requirements, and organize translation services for you, if required.

Please contact us to see how we may be able to assist you.