Statistical support for regulatory activities (EMA, FDA and world-wide)

Description of service

We can provide expert statistical support to the development of regulatory briefing material, response to questions and representation at face-to-face meetings. The interactions may include, but are not limited to:

• Submissions to local IRBs
• Special protocol assistance (SPA)
• EMA scientific advice
• US FDA meetings
• New drug applications

Why choose us?

• The decisions taken by regulatory authorities can make or break a product. It is therefore essential to find an experienced statistician who thinks logically and can articulate views exceptionally well both in written and verbal communication
• Nicola Little has a proven track record in this area. Her most recent experience includes designing the development plan for a lung cancer drug that started in Phase I in 2012 with an NDA submitted in 2015, less than 3 years later. She attended three FDA meetings and one EMA meeting during this period and was instrumental in crafting questions for the authorities, drafting company positions for the dossiers and providing written and verbal responses to questions posed by the authorities.
• Nicola also attended the FDA and EMA in 2009 and 2011 to discuss novel designs for two drugs – in the therapy areas of Oncology and Infection.