Within the context of my professional experience both as a freelance consultant and as manager of InSciSol, I have provided and supervised the following services:- Modules 2.4 and 2.5 of the CTD (Clinical Overview and Nonclinical Overview) - Consultancy on clinical and non-clinical requirements for regulatory submissions (well-established use, generic/hybrid applications, fixed-dose combinations)- Addendum to the Clinical Overview and the Non-Clinical Overview (where necessary) for renewal applications- Support for EMA Scientific Advice (consultancy, compilation of all relevant documents and presentations, physical presence of scientific consultants to the meetings)- Risk management plans- Biowaiver justifications- Toxicology assessment of excipients or impurities - PDE determination- Reports for the change in classification/legal status from prescription to non-prescription drugs- Safety reports for cosmetics and food supplements- Study design and protocol preparation (Clinical studies, Preclinical studies)- Compilation/Amendment of Product Information (SmPC, PIL)- Readability Testing (User Testing) of Package Leaflets- Medical writing