We are your representative every step of the way, from planning to the actual interactions with the agency.   

Health Authority Meetings 

We understand how critical these meetings are for Emerging Biopharma as they shape and determine the success of your product. Senita provides support for various health authorities or pre-submission meetings, including US FDA Type A, C, pre-IND, End-Of-Phase, pre-NDA, and pre-BLA meetings.

 

We’ll help you with: 

Timely communications with health authorities 

Preparation of the meeting request and briefing materials 

Identification of essential questions or requirements 

Practice sessions and coaching 

Post-meeting support to implement action items 

Expert advice for identified problemsStrategies enabling the Accelerated Approval and Conditional Approval pathway. 

Contact us today to learn how we can help you navigate the regulatory landscape and bring your innovative products to market faster.