Regulatory resources
Analyses, guides and benchmarks to understand healthcare regulatory affairs across Europe, the EMA and the UEMOA region.
Understanding the main frameworks of healthcare regulation
Three in-depth pieces to lay the foundations: how to structure a CTD/eCTD submission, European MA procedures coordinated by the EMA, and medicinal product registration in the UEMOA region. This content is regularly updated and complemented by new resources.
CTD / eCTDCTD / eCTD dossier: structuring a compliant regulatory submission
The CTD format, harmonised by the ICH and delivered electronically as eCTD, is the backbone of any medicinal product submission. A walkthrough of the 5 modules and key pitfalls.
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UEMOARegistering a medicinal product in the UEMOA region
The UEMOA region is gradually harmonising medicinal product registration. Overview of the regulatory framework, the expected dossier and the key steps to market.
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EMAEMA procedures: which route to choose for European market access
The MA procedure shapes geographic scope, timelines and launch strategy. A comparison of European routes and their eligibility criteria.
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SiraGroup supports healthcare stakeholders on CTD/eCTD submissions, EMA procedures and UEMOA registrations. Let's discuss your project and identify the most suitable route.