Regulatory Compliance
Regulatory compliance in translation refers to ensuring that translated content meets the legal, regulatory, and industry-specific requirements that govern how content must be produced, reviewed, and distributed in regulated sectors. Different industries have different regulatory requirements for translated materials, and non-compliance can result in legal penalties, rejected submissions, or compromised safety.
Key regulatory frameworks affecting translation include healthcare and pharmaceuticals (TGA requirements in Australia, FDA requirements in the US, EMA requirements in Europe, GCP standards for clinical trials), legal and immigration (NAATI certification requirements, court translation standards, immigration documentation requirements), financial services (regulatory disclosure requirements, ASIC compliance, international financial reporting standards), government (language services policies, multicultural access and equity frameworks, procurement compliance requirements), and food and consumer products (labelling regulations, safety information requirements).
Regulatory compliance in translation requires understanding both the content-specific regulations and the translation process requirements. Some regulations specify translator qualifications, review processes, or certification requirements. Others specify formatting, terminology, or content requirements for translated materials.
LEXIGO maintains current knowledge of regulatory requirements across the industries we serve, ensuring that translated content meets applicable standards. Our triple ISO certification (ISO 17100, ISO 9001, ISO 27001) provides the organisational framework for systematic compliance management across all client projects.
Regulatory non-compliance in translation can have serious consequences: rejected regulatory submissions, legal liability, product recalls, delayed market access, and compromised patient or consumer safety. For organisations in regulated industries, ensuring their translation provider understands and can meet applicable regulatory requirements is not optional — it is a compliance obligation.
Working with a provider that has specific experience in your regulatory environment reduces the risk of compliance issues and the burden on your internal compliance team to verify translation processes.