Scientific advice applications

Scientific advice

EuDRAcon will guide your company through the scientific advice applications in order to ensure that the medicines are developed according to European guidelines and according the current state of the scientific knowledge available so in the end to prove to be a good quality product with an effective and safe profile.

With our help the assessment process of your medicinal product application will be completed faster and the prospect of a positive outcome will be increased.

Protocol assistance

A specific form of scientific advice is the protocol assistance. This affects companies developing designated orphan medicines. Our network will make sure that your orphan medicine is granted marketing authorisation by demonstrating to the drug authorities its benefits, similarity or superiority to other such medicines. This is done after a comparison between the medicines indicated for treatment of the same symptoms/disease has been conducted.