Regulatory Affairs

General Regulatory Affairs services

Coordination of the entire Scientific Advice process, including preparation of the Briefing Package & application (local authority or EMA), briefing of advice participants and participation as regulatory expert during discussions with authorities

Writing, coordination and regulatory review of key scientific documentation required for successful Clinical Trial Applications: Investigators Brochure; Clinical Study Protocol; IMP; Application Form; Labelling
– Medical writing is outsourced to competent service providers in this field

Outlining the Regulatory Development Strategy based on company desires, relevant Regulatory Intelligence, applicable Guidelines and the Target Product Profile 

Experience in: Preparing, reviewing & submitting applications, amendments and notifications for Clinical trials in the European Union; CTA maintanence; Orphan drug applications; Due Diligence

Writing and reviewing Module 3 and 2.3 documentation for e.g. CEP or ASMF applications

The examples above are representative of key services provided within pharmaceutical development. My knowledge and experience within the regulatory framework, areas and procedures extents to many other activities also within the post-approval phase.

Please contact me if you have specific enquiries or require further information.