Sirius Regulatory Consulting has extensive experience in planning and managing successful scientific advice meetings with CHMP and National EU Authorities. Our philosophy is that pro-active scientific advice should facilitate, without delay, product development and regulatory approval. We work with our clients to:

• Develop and implement the optimal strategy for scientific meetings, including route and scheduling of scientific advice meetings
• Prepare high quality scientific advice documentation, with a focus on well worded scientific advice questions and
  robust/persuasive company position statements
• Prepare for, and manage, successful scientific advice meetings with the regulators

Scientific advice discussions provide an opportunity to significantly reduce the risk of regulatory failure. Sirius Regulatory Consulting will support you in all aspects of scientific advice, negotiating for regulatory authority agreement and maximising the value of advice received.