The EU Paediatric Regulation imposes significant obligations on the pharmaceutical industry to address the potential need for paediatric development as a prerequisite for approval in the adult population. In return, incentives are offered as a reward for addressing these challenges.

Sirius Regulatory Consulting supports clients to:

• Prepare the optimal strategy for compliance with the Paediatric Regulation
• Complete Scientific Advice discussions to obtain regulatory authority input to, and validation of, the proposed paediatric
  development
• Prepare and manage the submission of Paediatric Investigation Plans
• Negotiate for success with the Paediatric Committee

Sirius Regulatory Consulting supports clients in achieving compliance with all paediatric regulatory obligations, while maximising the potential rewards.