About Us
Meet the team
Services
Clinical Development Strategy
Clinical Regulatory
Innovator Support
Gap Analysis of US/other 3rd country dossiers and older dossiers for suitability for submission in Europe
EU EMA and National agency dialogue and associated procedures
Compiling and publishing European compliant MAA submissions
Product Lifecycle Management
Major CMC changes
Medical Devices and IVDs
Combination Products
Abridged applications
Regulatory Compliance and Quality System Management
Resources
Case Studies
Real Reports
News & Events
Contact
Real Case Studies
6 Sep 2021
Preparation of an EU regulatory strategy plan for a US client
25 Mar 2021
Adaptation of IND to IMPD for submitting in EU countries
2 Feb 2021
Application for EU advanced therapy medicinal product (ATMP) classification and orphan drug designation (ODD)
16 Nov 2020
Converting a 505(b)(2) NDA from the United States into a European MAA
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