Module 17 2024

05/12/2024

Company Interactions with Regulatory Authorities

Geoff Fatzinger

Founder & Chief Consultant

Alexavi Biotechnology & Pharmaceutical Services

December 2024.

117

Protect the patient •Agency is responsible for ensuring that companies have acted responsibly

Protect

Enforce the law Enforce

Role of Agencies

Help the company •Yes, its true. They are there to help industry as well

Help

Assess need for new regulations •The system is dynamic, what works today may not work tomorrow. Every situation is different

Assess

118

59