Examples of services I provide
· Regulatory support and/or management of regulatory work in drug development projects.
· Advice on regulatory strategies.
· Arrange for scientific meetings or regulatory advice with European Regulatory authorities.
· Compilation, submission and follow-up of clinical trial applications, marketing authorisation applications and variations.
· Review of documentation including gap analysis of the quality part of documentation (Module 3) in clinical trial and marketing authorisation applications.
· Follow-up and interpretation of European and national regulations, directives and guidelines.
· On site management of Regulatory Affairs units.
· On site project management in pharmaceutical development of drugs.
· Business development in Regulatory Affairs and pharmaceutical drug development.
· Teaching- and investigational commissions in drug development and closely related business.
Upon customer request I also interact with other experts and consultants. If I have no possibility to take on a commission I can propose other consultants.