Deep expertise in US and Europe drug development working within a project matrix team environments to provide clients with innovative and streamlined regulatory strategy and operational support from inception to commercial filing.

Interim Head of Regulatory

• Structure, build and lead

• Partner in search for permanent leadership

Global Regulatory Strategy & Execution Support

• Gap analysis

• Integrated product development planning and execution

• Target Product Profile (TPP)

• Generate/execute regulatory pathway

• Due diligence

Global Regulatory Preparation & Submissions

• BLA / MAA (for commercial)

• ODD / RPDD (for rare disease)

• PIP (for Pediatrics)

• CE-marking (for combination device and companion diagnostics)

• CLIA/IDE (for companion diagnostics)

• EU GMO (for gene therapy)

Regulatory Agency Interaction

• Agency interactions - INTERACT, Pre-IND, End of Phase 2, Protocol Assistance, Scientific Advise, RMAT, PRIME, ITF, Competent Authority Meetings

• Regulatory agency interactions with patient groups