Clinical and non-clinical sections of the registration dossier

DADA has prepared more than 1000 state-of-the-art expert reports, clinical and non-clinical overviews that have been successfully included in marketing authorisation applications approved throughout Europe. DADA guarantees compliance of its expert reports and (non)clinical overviews and guarantees delivery of good quality documents within the timeframe agreed upon with our customers.

Often, clinical and non-clinical overviews and Summary of Product Characteristics are not written by the same experts, or even the same sub-contractors. This can lead to discrepancies in information and confusion during registration procedures. DADA can review these documents and make necessary amendments in order to coordinate the information provided. DADA guarantees that when clinical and non-clinical overviews and SmPCs are written by our experts, no discrepancies can be found.

In the EU, it is possible to apply for marketing authorisation based on well established use. The clinical and non-clinical information provided in the dossier for these applications are largely based on literature data. DADA is capable of writing the full clinical and non-clinical parts of the registration dossier based on literature for well established use applications. For marketing authorisation applications that are based on a mixture of information from literature and clinical and/or non-clinical trials, DADA is capable of writing the literature part and coordinating the dossier parts to include the information from trials performed.