Services: Regulatory Affairs
Combining our specific EU and US experience in regulatory affairs with
our long history of working with the FDA and EU Agencies, we can provide
unique capabilities in the preparation of the clinical sections of a
CTD with efficient writing deliverables (MIRS-Message, Issue, Response,
Support).
• Preparation of IB, briefing documents,
IND and CTA;
• Agency liaison and meetings management;
• CE marking of devices;
• Technical writing for NDA/MAA submissions.
