Bringing Life-Saving Pharma Products to Market Across the World

The Challenge

Our client needed a partner who could translate the Registration Dossier for their pharmaceutical products for market approval in Asia, Russia, Latin America and Africa.

Although the format and structure of the dossier must follow strict rules and guidelines, the language requirements for submission can differ from country to country; some countries, such as China, often require documents from all Modules to be translated into Chinese for submission. Other countries typically only require documents comprising Modules 2 (M2) or 3 (M3).

With respect to translation, Modules 2 and 3 are the highest in volume as they contain all of the clinical study summaries and overviews, the individual studies and reports and quality data. A typical dossier from the client containing all of Modules 2 and 3 is, on average, around 500,000 words. The typical turnaround time required for translating such a volume is 3-4 months. A challenge in itself but add to that the complexity of the content (biochemistry, pharmacology, virology), the format requirements (many documents in Pharma dossiers are un-editable PDF files that come from 3rd party labs) and the need for innovative translation solutions becomes essential.

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Large

Volumes

schedule

Tight

Deadlines

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Difficult

Formatting

The Solution

Acolad’s first dossier project for the client was translating M2 and M3 documents into Latin American Spanish for one of their core HIV therapies. The total volume was over 300,000 words and the client needed it delivered within 8 weeks! Although the majority of documents were Microsoft Word format, they were large and complex and formatted according to CTD standards which needed to be maintained in the translated equivalents. There were also a lot of PDF files, for the most part un-editable and highly repetitive in content.

Acolad’s technical team quickly recognized the need to find a solution that would enable the use of CAT with these files if we had any hope of meeting the aggressive deadline. They were able to devise a process of ‘preformatting’ the PDF files in Microsoft Word according to CTD templates which then allowed the content to be processed in MemoQ, taking full advantage of leveraging the repetitions, resulting in enormous time and cost savings. Benefits that did not go unnoticed by the client who, after the success of this first project, returned to Acolad just one month later to request translations for an even larger dossier for South Korea and subsequently the first large dossier translations for China and Russia.

In addition to providing technical solutions through savvy use of TM technology, the volume and complexity of the client’s content required Acolad to provide an extremely high level of subject matter expertise in its linguistic teams, made even more challenging when 10-15 translators were often needed in order to meet the challenging deadlines. Acolad’s vendor management team has worked continuously over the years to recruit and certify linguists specialized in pharma submissions with whom to partner on our client’s work. Very strong relationships have been formed with teams in Latin America, China, South Korea and Russia that have allowed Acolad to always have the right number and quality of resources ready to take on this work whenever the client requires, often at relatively short notice.

The Results

Harnessing Technology to Ensure Efficiency

No missed deadlines
30% savings
Faster time-to-market

Continued innovation in TM use, dedicated linguistic teams and overall excellence in customer service (the client will often cite the fact that Acolad has never missed a deadline) has enabled them to not only meet their submission deadlines and quickly make their products available to patients world-wide, they have also saved money in the process! Acolad’s service has become increasingly efficient and cost effective, providing savings of up to 19% year-on-year.