Medical Device and pharmaceutical companies are now almost exclusively global in their outlook, taking their products all over the world. This globalization has provided a wealth of business growth potential but has also created a number of challenges.
A significant one is the need to ensure that registration dossiers and other documentation, including patient-facing materials, are precisely, consistently and accurately translated for each new market in line with the current local requirements. Some markets are harder than others and the translation workloads involved for China, for example, are immense. It is common to be expected to turn around up to two million words of certified translations for these dossiers within as short a time frame as two to three months.
The risks with local language support
Such translations have typically been devolved to local teams, which are supported by local translation agencies. However, in doing so there can be a significant variation in the quality of translations as well as sharp differences in the look and feel of translated content.
Many such satellite operations primarily comprise sales and marketing staff, who can lack the capacity and project management skills to organise and keep on top of regulatory content translations. When you factor in the need to stay on top of ever-changing regulatory requirements and their bearing on translations for the local market, the size of the risk associated with local language support becomes clear.
Even in a more established market such as Europe, the demands are substantial. Currently there are 24 languages to whom you must cater, for the EU’s centralised authorisation procedure. Broadening out to Europe as a whole, including eastern Europe, increases the regional translation burden to more than 30 different languages.
Furthermore, Brexit has shown that EU membership isn’t set in stone, and such changes in membership could have implications for the dominance of the English language in regulatory administration, once the European Medicines Agency has reoriented itself on the mainland.
Centralized translation is the smart option
With a rapidly expanding translation requirement, organizations’ best hope of keeping its growth strategy on track is to have a holistic, end-to-end approach and system for tracking evolving international regulatory requirements, and for delivering timely and accurate local translations for each target market.
This means that a centralized, systematic approach to the coordination and execution of translation projects is becoming the smart option, enabling greater consistency, cost-efficiency and a clear line of sight across workloads. It also paves the way for additional efficiencies – such as those enabled through the strategic application of technology in helping to process translations.
The value of life sciences content specialists
Managed regulatory translation service providers which specialise in life sciences content – such as AMPLEXOR - will have pools of resources, skills and experience that companies can count on and draw on as needed. There are also ways to accelerate delivery, such as by harnessing translation memory technology: software that can automatically draw on specialist, agreed phrasing and terminology in the target language, from previous use cases.
This means that the longer an organisation continues to use the same provider to manage translations, the faster the output. With some dossiers running to two million-plus words, it’s easy to see how using this technology is essential to ensuring that tight deadlines of two to three months can be met with a small, dedicated expert team.
Although wide-spread, next-generation automation using artificial intelligence and machine learning for medical content may be some way off given the sensitivity of the content and the ‘life-or-death’ requirement for accuracy, such capabilities are advancing all the time and, in due course, are likely to add significant value to automated translation opportunities for life sciences. A good translation partner will have this kind of technology built into its technology automation roadmap.
Many life sciences firms may already have too much on their plates to contemplate tracking, project-managing and quality-assuring international regulatory translations and submissions, despite their importance. It is for these reasons that end-to-end translation management services have become so vital.
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Nancy Pollini is director of strategic accounts for language services at Amplexor Life Sciences