For pharmaceutical companies located outside the EU, drug development and regulatory strategies are often focused on meeting local requirements without the need to consider EU regulatory needs.

Sirius Regulatory Consulting supports clients to utilise ex-EU drug development programmes to access European regulatory approval. We focus on achieving EU regulatory acceptance of the ex-EU data package and minimising time to market. Our structured approach includes:

• Gap analysis of development programme and/ or regulatory dossier versus EU regulatory requirements and expectations
• Preparation of recommendations/ strategies to bridge any identified gaps
• Scientific Advice discussions with EU authorities to ease acceptance of the ex-EU data package

We provide practical regulatory support and guidance to assist companies in establishing the local infrastructure required to meet the obligations of a European Marketing Authorisation holder.

Whatever the needs, and whatever the challenges faced, Sirius Regulatory Consulting will support you in achieving your objectives.