FOCUS Regulatory Affairs Ltd

Our experts provide comprehensive regulatory services with special competence in early drug development. We have access to the latest information on newest developments in the EU and German pharmaceutical laws as well as on Russian laws and offer assistance on related specific questions:

• Regulatory Intelligence
• Registration strategy
• Authority communications
• Orphan Drug Status
• Pre-submission meetings
• EU clinical trial regulations
• IMPD file compilation
• Regulatory compliance advice
• US-IND preparation
• Scientific data review
• cGMP-manufacturing review
• Pharmacovigilance
• Expert report writing/CTD preparation
• Medical device regulations
• Legal entity service for sponsor firms residing outside the EU

Consultancy and preparation of documents is provided in close cooperation with our clinical research and pharmaceutical (CMC) experts.