Global Regulatory Affairs

Our expert medical writers are able to make your dossier “Registration Ready” for whichever market you are going in to.

We can take an old format dossier such as Notice to Applicants (NtA), Non-eCTD electronic Submission (NeeS) or CTD, prepare a gap analysis and then align it to the latest standards.

Moreover, we use industry standard eCTD software for electronic submissions in order to provide a comprehensive solution.

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If you are interested in our service please contact us for more information.

Telephone+353 125 44033

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