Case Study: Biotechnology Company Expands Globally

Case Study: Biotechnology Company Expands Globally

Our client:

Headquartered in Incheon, South Korea, our client is a global leading biotechnology company primarily handling biosimilars, novel biologics, and CMO. Having succeeded in becoming one of the first companies in the world to obtain a license for novel biologics, it is now a $10 billion company in Korea.

The Situation:

New drugs, global R&D and global clinical studies in the pipeline requiring lots of translation work. FDA and EMA Regulatory requested the certificate of accuracy for all documents starting from 2017.

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The Challenge:

Our client is based in South Korea, while several of the world’s influential life sciences agencies, such as the FDA and EMA are located in the US and Europe—thus, operating in different time zones and speaking different languages. In the initial stage, the Donnelley Language Solutions, which is now part of SDL, team invested a lot of time delving into the company’s needs and pain points. They needed a language provider who can deliver with fast turnarounds, offering local support, industry expertise, extensive language coverage as well as language support for all certifications requested by different authorities.

In this highly specialized field of drug development, it was important to achieve consistency and accuracy of terminology across all documents within the tight deadlines.

The Result:

We proposed a customized solution based on our extensive experience in the pharmaceutical industry, resulting in a smoother operation and increased efficiency. Our teams worked closely with the client to establish an optimal workflow and schedule to process the large volume of translations in a defined timeframe. A dedicated team of project coordinators assembled a strong team of professional and experienced linguists. Each had a proven track record in healthcare, specializing in certain areas, including biosimilars, and were ready to work on the projects as scheduled.

The range of languages translated was extensive: from Korean into English and Japanese, and from English into Chinese, Russian, French, Spanish for Latin America, and Brazilian Portuguese.

In addition to local support via a dedicated production team in Asia, we helped the client establish itself internationally by providing global coverage: 31 offices on four continents, ensuring support 24/7/365.

A translation memory was also created and extensively used to meet the challenges of turnaround times and consistency.

Our client is one of the most successful biotechnology companies in South Korea in terms of revenue, estimated to reach 2.5 trillion South Korean Won (USD 2.3 billion) in 2020.  We helped them translate various highly regulated documents such as CTDs for NDA filings. In addition to translation, we provided sworn translation, transcription, DTP and website localization. Our capabilities in delivering all projects on-time, coupled with local market knowledge, high-quality translation, and industry expertise, are highly appraised by the client.

We’re their primary language service provider. Last year, we provided translations that helped them obtain FDA approval for a groundbreaking monoclonal antibody medication. Following FDA approval, we went on to assist them with the drug’s global product launch.

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