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Case Study | Module 3 Regulatory Compliance of full portfolio

August 2, 2023

Have a look at a recent success story of how Asphalion helped an international European pharmaceutical company with a wide portfolio of medicinal products and important discrepancies between the registration documentation and the quality/manufacturing documentation, aiming to achieve full M3 dossier compliance.

Thanks to our extensive track record of over 20 years at Asphalion we can assist you to choose the right strategy, optmizing costs and enhancing time-to-market, and with all other kind of activities and projects.

Case Study Asphalion_Marketing authorization expansion in Europe

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CTIS applicable | Faster Access to Clinical Trial Information in Europe

CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

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