Performance Under Pressure
The pharmaceutical industry deals with stringent regulations from government agencies worldwide. From getting a medicinal product approved to entering a new market, pharmaceutical companies must submit numerous translated documents to comply with local language requirements. Strict regulatory translations are expected, given the responsibility to ensure the safety, efficacy, and quality of the drugs available to consumers.
Brazil: One of the Largest Pharmaceutical Markets in the Emerging World
Brazil has a challenging and complex regulatory environment. Anvisa, the Brazilian Health Regulatory Agency, is among the strictest and most demanding in the world. With a population of over 212 million, it’s the largest country in South America. And it also happens to be globally, with a market value of nearly $21 billion.
One of Welocalize’s clients is one of the largest global pharmaceutical companies in Brazil. With headquarters located in Basel, Switzerland, our client is the world’s second-largest pharmaceutical company based on prescription drug sales. A large part of their revenue comes from innovative medicine unit, consisting of a primary care business and an oncology business. However, it also has a competitive generic drug division with Sandoz.
Since 2012, the client has turned to Welocalize Life Sciences as its collaborating partner to translate registration documents, with over 500,000 words translated each month into 10 languages. The client required 200,000 words to be translated for the Brazilian market, including handwritten documents, from English to Portuguese-Brazil. This usually takes a month to complete. However, the client needed it in six days:
Agile Translation for Regulatory Documents
This was when we took an agile approach to regulatory translations. Agile is a project management methodology popularized in software development and adopted in other kinds of projects, such as localization.
The key principle in agile localization is to break up parts of a project into smaller, manageable content chunks so teams can work on them simultaneously. Instead of working on a document in sequence from start to completion, teams manage segments in sprints or short bursts of work. They collaborate frequently, so they can tackle problems fast.
For the client’s localization project, we first made sure we were prepared before we even started. We ensured terminology coherence by using glossaries and automated QA checks. We also implemented a combination of translation memory (TM) and neural machine translation (NMT) to pre-translate all the content.
Then, we divided the content into batches, assigning them to different teams that worked on them simultaneously. For instance, we worked with multiple formatting teams in parallel. We used native speakers to retype handwritten text. We assigned the content batches to a pool of dedicated linguists for post-editing and editing work with rolling deliveries.
Instead of waiting for all the documents to be completed, we worked with several quality control (QC) specialists in parallel to prepare the final deliverables.
Follow the Sun Approach
Just so we maximized our global network of linguists, we worked across multiple time zones. We could not be burdened and slowed down by a fixed 9-5 schedule, so we spanned our project team across Asia, Europe, and Latin America. We deployed multiple teams to work in various time zones around the clock, 24 hours a day, to optimize time and efforts.
We have teams of highly qualified and specialized language professionals who work within the framework of regulated processes and robust QC systems to provide translations. They have experience translating regulatory documents, including summaries of product characteristics, product information leaflets, labeling and packaging, marketing authorization dossiers and variations, manufacturing and packaging guides, and validation protocols and reports.
Technology to Stir Up the Process
Welocalize complements our human linguists with localization technology and machine automation to create, annotate, and augment high-quality training data for machine learning (ML) and artificial intelligence (AI) initiatives.
We used innovative technology for the client’s project in the Brazilian market, including an automated central workflow system. This enabled our teams to streamline the translations. Close collaboration with our client allowed the provision of live feedback, meaning corrections are made immediately and throughout the localization cycle, not just at the end.
We also used machine translation (MT) to speed up the process and global terminology libraries and TM to keep translations consistent across all content.
Six days later, the client was able to submit batch records to Anvisa on time and of top quality:
“The overall understanding of the market’s needs, especially deadlines related to national administrations, is excellent. Collaborating and partnering with Welocalize ensured matching our deadlines with the highest quality,” says José G. Martinez-Figueroa, Director of Regulatory Affairs – Latin America & Canada, Global Drug Development.
Work With Welocalize Life Sciences
Welocalize Life Sciences specializes in expert translation and localization services for global clinical trials, pharmaceuticals, biotechnology companies, medical devices, healthcare brands, and medical companies. We deliver timely, accurate, and submission-ready translations while mitigating risk and adhering to the highest quality controls.
Our client chose Welocalize Life Sciences for its high-volume, time-sensitive translation projects. Challenge us to do the same.