Effective drug development and regulatory strategy are the foundation of regulatory and consequential
commercial success.
We support our clients in all aspects of regulatory and drug development strategy, including:

• Advice on EU legislation
• Development of target product profiles/ Summary of Product Characteristics to guide product development to achieve
  commercial objectives
• Optimisation of product development programme to achieve commercial objectives and address regulatory expectations
• Scientific advice
• Orphan designation applications
• Paediatric Regulation compliance strategy
• Analyses and recommendations on optimal regulatory strategy
• Conditional approval, approval under exceptional circumstance or accelerated assessment

Sirius Regulatory Consulting will assist you in developing drug development and regulatory strategies that focus on achievement of your commercial objectives, while meeting regulatory expectations and requirements.