Broad Areas of Expertise
Small Molecules, Biotechnology Products, Vaccines
All Key Therapeutic Areas
Clinical and CMC
Expertise Across Regions - US, Canada, EU, RIC, Asia
Strategic Communications
Preparation for Global Agency Milestone Meetings
Briefing documents, Rehearsals, Chair meeting
Key Message Development for Submissions
Review Q&A and Post Filing Meetings
Specialty Applications
Orphan Drug Designations
Accelerated Approval
Fast Track and Breakthrough Therapy
Priority Review
