CTD modules 2.4, 2.5, 2.6 and 2.7
During the more than 20 years of my freelance work, I have successfully prepared expertises for the approval of new medicines, generics and biosimilars. Another focus of my activity is the preparation of medicinal dossiers according to the rules of "well- established medicinal use".
Handling of deficiency letters
Consultancy and co-operation in project teams / drug development teams
with the focus on Clinical Pharmacology, Pharmacology and Toxicology relating to the future registration of the product candidate.