Regulatory support to understand likelihood of approval of an ophthalmology asset

Challenge:

A European pharmaceutical company focussed on ophthalmic care was seeking Well Established Use (WEU) approval in Europe for a small molecule asset. The company commissioned Alacrita to conduct an assessment of the likelihood of gaining approval under this pathway and to develop a briefing package to support a scientific advice meeting to discuss the proposal with a European regulator. 

Solution:

Our regulatory experts first conducted an in-depth review of current literature on the asset and developed an understanding for likelihood of achieving WEU approval based on available data in the field. 

We concluded that there was sufficient evidence and worked with the client to gain confirmatory feedback from the National regulator through a scientific advice meeting.

Alacrita's Regulatory Affairs Support

Our regulatory affairs consultants can help you devise effective regulatory strategies to place you on the best path toward regulatory approval, helping you avoid regulatory delays and overcome critical regulatory hurdles. We also provide hands-on support, including assistance with regulatory applications and eCTD publishing.