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Innovation
Product Develoment
CTIS – Insights of the new system’s challenges
We guide you through the key features of the Clinical Trial Information System (CTIS) to help you successfully submit your trial applications and manage the transition process.
Product Develoment
Prime Scheme – A Tailored Development
Medtech
Clinical Validation of Software Integrating AI
Pharmacovigilance
Integrating Local PV System into Global PV System
Quality compliance
Annex 1 Changes and challenges: a concrete return of experience from the clients
Product Develoment
Acceptance of NDA/MAA with only Chinese Patients by Western Regulatory Agency