Regulatory compliance is a key part of day-to-day business for many of our clients, particularly in the medical profession.
In order to sell medical products and pharmaceuticals in international markets, companies must fulfil extensive linguistic requirements to guarantee that their products comply with current legislation. This means documentation must be accurately translated into the relevant target languages for each market. As this environment grows ever more complex, many companies are choosing to outsource pharmaceutical regulatory affairs and quality assurance to ensure compliance with the law.
Our medical division has decades of experience providing translation for regulatory compliance and works with a global network of more than 2,000 regulatory affairs specialists.
We can offer advice and support at each stage of a medical product’s development, or a new drug’s lifecycle – from manufacturing, through to labelling and instructions for use. We ensure all the relevant documentation complies with national and international standards, such as those required by European Medicines Agency or the US Food and Drug Administration.
Over the years, we have provided translation services in support of everything from global clinical trials to translation of consent forms, labels, package inserts and instructions for use.