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.

Development and creation of dossiers for Scientific Advice (e.g. Briefing Book), participation in discussions with the regulatory authorities, presentation, wrap-up

Co-operation in and/or management of a Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB)