Companies with regulated activities are those in which the content needing translation is sensitive, is subject to regulation and legislation, or requires comparative research in sources from other countries.
In regulated activities, accuracy is particularly important, because any nonconformities may lead to a loss of reputation, if not sanctions.
This must be managed according to the ISO 13484 standard, for which Yellow Hub is certified.
In outsourcing multilingual documentation in this industry, we adopt a risk-based approach in all essential processes and support procedures envisaged by ISO 9001, as well as practices for continuous improvement, and the selection and training of collaborators assigned to projects for the pharmaceutical and medical device sector.
For these types of documents, the constraints relate to rigid legal expressions drawn from research into codes and sources of comparative law, as well as judicial verbiage.
Content in this sector is destined for both investors and regulatory authorities.
Content in foreign languages must be managed very precisely, without ambiguities that would otherwise produce misunderstandings and deceptive information, leading to inopportune corporate decisions or management, as well as legal consequences.
