Maxer applies the Clinical Trials Disclosure and Data Transparency requirements set by EMA and FDA. The disclosure team has developed specific skills regarding the European, British, and US regulations on the transparency of clinical studies and, limited to the EMA area, drafting layperson summaries and anonymization and editing – manual and semi-automatic – of registration dossiers.

Besides, it has to his credit the drafting of preclinical and clinical modules of the CTD relating to new registrations of products already consolidated in clinical use.