How we supported the client
We assisted the client by providing guidance on the filing requirements and process in Switzerland and other countries, identifying potential critical steps and developing a comprehensive filing plan with a clear timetable and key deliverables. We provided ongoing management of any ad hoc issues that arose. Additionally, we identified and subcontracted an experienced partners to support the project as the MAA holder in Switzerland.
Strategic
Regulatory
Advice
Interactions with Health Authorities
Submission
Management
Partnering with Industry Experts
Strategically laid out options when and where to go for scientific advice in Europe by weighting national versus central advice based on client`s needs and planned development program
Wrote the scientific advice package
/ orphan designation as well as reviewed
Advised on opportunities of acceleration options in Europe
Submitted a request for a SME
(micro, small and medium-sized enterprises)
