Services during project development

Development and drafting of the full application of drug registration dossiers
Management of registration dossier submission in electronic format (Nees and Vnees)
Development and drafting of the part concerning administrative data, Summary of Characteristics and package leaflet.
Experts reports about chemistry-pharmaceutics, pharmacology-toxicology and clinics (tabular and summary)
Coordination of each and every one of the experimental studies that make up the project
Documentation management of the studies to be carried out
Development, drafting and management of the documentation for the clarifications requested by the Spanish Drug Agency
Conducting the necessary studies to demonstrate the quality, safety and efficiency of the drug in question