Dr Deborah Scholey, PhD. F.Topra, Regulatory Affairs

Deborah is an experienced regulatory professional with over 25 years’ experience in the drug development industry. Her experience has been acquired in both small and medium sized companies and CRO’s and for the last 8 years as an independent regulatory consultant. She has a breath of regulatory experience covering US and the EU and has worked in a variety of therapeutic areas including neurology and psychiatry. She provides both operational and strategic support including:

• Early drug development planning
• Management and preparation of Clinical Trial Applications
• Preparation and management of pre-submission/scientific advice  meetings with health authorities
• Orphan Drug applications for US and EU