Business Case detail

CTD from Japan to GCC

Project: CTD from Japan to GCC

Client: Spimaco, Saudi Arabia

Summary of Project: Translation Management of a Dossier In-Licensed from Japan.

We were requested by a large Middle Eastern company to translate into English a dossier that they wished to in-licence from a Japanese company. This would then be registered in GCC.  The document had over 2.7 million Japanese characters.

Issues:

Over 70% of the source documentation in Japanese were scanned documents which were deemed to be “poor” or “very poor” in terms of quality.

This  meant it was necessary to completely recreate such documents (drawing on all of the many Desktop Publishing skills required to manage this) as well as maintaining compliance with the GCC CTD requirements (required regulatory input from two continents).

Solution:

The Project Management department took the dossier and after careful review decided that the only feasible way to manage such a project with the added issue of the document quality was to organise translation teams.  This would increase the likelihood of meeting a very challenging deadline and to ensure that each module was clearly understood. Chemists, Pharmacists and Medical Doctors were the core of the translation team, all of whom had many years translation experience. 

The first stage was to focus on the extraction of Japanese characters and begin the work of rewriting the dossier.  A “simple” translation was not feasible in this circumstance. 

From this point on the translation began, which was overseen by expert proof readers. In order to maintain that the translation teams QC/QA process was kept fluid, the translation teams, on a weekly basis, provided updated translated text to the proof reading team. 

Our Regulatory Affairs department worked on each section of the translated text and coordinated closely with our publishing department to create an eCTD dossier.

Finally, we successfully registered the dossier in the GCC region through our affiliates on time.

Conclusion

This project took 6 months from start to finish.  It was not as it was originally stated by the client as a translation project.  The only way we were able to deal with such a task was to calmly use our experience to break down each element of the project. 

Our advantage was that because we are an integrated service provider, we were able to bring in all relevant key personnel from our teams of Regulatory Affairs, Translations, Graphic Design/Desktop Publishing (DTP), Medical Writing and even Pharmacovigilance.  Without this breadth of expertise in our company, alongside our Vendor network, it would have been an almost impossible task!