Scientific Advice

• EMA: Scientific Advice & ITF Briefing Meeting, Pre-Submission Meeting
• Member State Scientific Advice
• FDA: Pre-IND, EOP2, Pre-BLA

Regulatory Dossier-Compilation and Maintenance

• Compilation and evaluation
• Completeness and Gap Analysis
• Preparation of submission in CTD/eCTD/NeeS format
• Support in creating Module 1-5 for all procedures according to National/EU/US requirements

Regulatory Dossier-Compilation and Maintenance

• DCP slots blocking and management
• Transforming/ creation of eCTD format
• Variations-CMC and Safety
• Renewals of MAs
• Sunset clause monitoring and solving (EU)
• Liaison with authorities

EU Batch Release Services