Bringing life-saving products to market across the world

Learn how Amplexor, an Acolad company, helped a global pharmaceutical company reduce costs associated with regulatory submissions translations worldwide with a customized content process and cutting-edge translation memory technology.


The Client

Our client is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Their portfolio of products includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions.

The Challenge

  • Large volumes of content
  • Tight deadlines
  • Complex formatting requirements

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.

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, complex and formatted according to CTD standards, which needed to be maintained in the translated equivalents. There were also several PDF files, for the most part uneditable and highly repetitive in content.

Our technical team quickly recognized the need to find a solution that would enable the use of CAT tools with these files if we had any hope of meeting the aggressive deadline. 

We 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 resulted in enormous time and cost savings. Benefits that did not go unnoticed by the client who, after the success of this first project, returned 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 translation memory technology, the volume and complexity of the client’s content required 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. 

Our 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 us 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 Result

"Amplexor has never missed a deadline!"
The client
Continued innovation in the use of translation memory technologies, dedicated linguistic teams and overall excellence in customer service (the client will often cite the fact that we've 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! As their global content partner, our service has become increasingly efficient and cost effective, providing savings of up to 19% year-on-year.

Learn how we provide end-to-end language support for every phase of the product lifecycle