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Services
Clinical Development Strategy
Clinical Regulatory
Innovator Support
Gap Analysis of US/other 3rd country dossiers and older dossiers for EU suitability
EU EMA and National agency dialogue and associated procedures
Compiling and publishing EU compliant MAA submissions
Product Lifecycle Management
Major CMC changes
Medical Devices and IVDs
Combination Products
Abridged applications
Regulatory Compliance and Quality System Management
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Real Case Studies
16 Nov 2020
Converting a 505(b)(2) NDA from the United States into a European MAA
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