• Strategic analysis and decision making• In depth assessment of condition and disease environment• Understanding of competitive plans• Clinical studies design from early stage to post registration• Identification of the right outsourcing partners• Regulatory strategies for approval
•Specific design from early stage to post registration•Regulatory requirements•Ethics specifications•Operational solutions with highly experienced network•Close collaboration with family and patients associations
Successfully navigate complex regulatory pathways and requirements
Sponsor support during regulatory interactions with the Competent Authorities and the Relevant Agencies
• Assessment of the paediatric needs •Potential drug positionning • Regulatory environment
