PublicationFDA

Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

This article, the second in a two part paper highlights the main challenges faced by marketing authorisation applicants for the conversion of a dossier from one region to another, and deciding between a sequential and a parallel preparation.

June 2015 – Regulatory Rapporteur

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publication by

FRÉDÉRIC PAILLOUX, PHARM.D., M.SC.

Nathalie Boeglin

Director Regulatory Science Drugs & Biologics

Alice Rolland

Regulatory Scientist Drugs and Biologics

Davis Uguen

Executive Director Drugs and Biologics

Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

Download the full publication now

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Preparing a Drug Registration for the US and the EU Parallel or sequential applications – Part 2

Download the full publication now

publication by

More resources

Achieve Success for Your First US Product Application – Pathway to IND

Sponsors of Clinical Trials in the EU/EEA – Call for Action!

Demystifying the US IND process for initiation of clinical trials

Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…