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Pharmaceutical Regulatory Affairs

Day Zero ehf is an Icelandic company formed in 2013, specialising in providing high quality CMC, Pharmaceutical Regulatory Affairs and Translation Services to Applicants and Marketing Authorisation Holders in the EU/EEA.

We are members of the EuDRAcon network.

CPhI 2016

We will be at the CPhI 2016 in Barcelona. Contact us to set up a meeting.

Regulatory Services

MA submissions

- National Submissions
- Mutual Recognition   Procedures
- Decentralised Procedures
- Centralised Procedures

Life Cycle Management

- Variations
- Renewals
- RMS/CMS transfers
- MAH transfers
- Withdrawals

Translations

Translation of Product Information and MAA documents from English and Scandinavian languages to Icelandic and from Icelandic to English.

Dossier Compilation / eCTD

Day Zero ehf offers various services in dossier compilation and preparation for submission:
- Dossier conversion to eCTD
- Audit of the quality part of the dossier
- Compiling Module 3, writing of Module 2.3
- eCTD training

Day Zero ehf develops and sponsors free eCTD software. The eCTD indexer is published with an open source licence and can be downloaded from Sourceforge. See also http://ectd.is.

Pharmacovigilance

Day Zero ehf maintains a registered PSMF and can provide various PhV services, including xEVMPD data entry. Please contact us for further details.


Report side effect / Tilkynna aukaverkun
To report side effects, please call (+354 659 4144) or email us. Please detail the suspected product, the side effect and contact details.
Vinsamlegast hringið (659 4144) eða sendið tölvupóst til að tilkynna aukaverkanir. Vinsamlegast tilgreinið lyf, aukaverkun og aðila sem má hafa samband við ef þörf er á frekari upplýsingum.