The EU has specific regulations demanding highly specialised skills and expertise and we fit in rightly into the spectrum of EU procedures and regulatory demands to formulate regulatory strategies.
EU Regulatory Strategy
Clinical Trial Application – EU CTR
CTIS (Part 1 and Part 2 documents)
IVDR Applications
Medical Writing for Protocols
Scientific Advice and Pre submission Meetings
Marketing Authorisation Applications
Post Approval and Lifecycle Management
Variations including quality and extension of indications
