• Global regulatory strategy from pre-clinical to post-marketing for drugs, devices, drug & device combinations and advanced therapy products
  
  
• Interaction with regulatory agencies and notified bodies
  
  
• Writing and preparation of IMPD, CTA, IND, IDE, PIP, RFD, IB, and briefing packages for agency meetings
  
  
• Compilation and publishing of registration dossier (eCTD) for MAA/NDA/BLA
  
  
• Application for orphan drug and SME designation
  
  
• Communication of industry interests to trade associations
  
  
• Assessment of in-licensing opportunities and due diligence
  
  
• 'EU-Agent' for SMEs
  
  

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