Regulatory submissions can be complex and challenging due to strict and ever-changing regulations and deadlines set by local authorities. Companies must manage language and cultural differences across countries, ensuring compliance and effective communication with diverse regulatory bodies.
Our Marketing Authorizations and Labelling solutions can take the burden of your regulatory submissions, providing high-quality, timely translations that adhere to specific regulatory requirements and guidelines
The IQVIA Market Authorization Language Suite simplifies multilingual Common Technical Document (CTD) submissions. Designed for regulatory affairs teams, it ensures linguistic precision and compliance across Modules 1–5, accelerating approvals and minimizing rework.
Ensure your marketing authorization application adheres to local regulatory guidelines, reducing the risk of non-compliance and improving the chances of approval.
IQVIA’s Market Authorization Language Suite supports regulatory teams in delivering compliant, high-quality translations of Product Information—SmPCs, PILs, and labeling—aligned with CTD Module 1 requirements. Our linguists specialize in life sciences terminology and EMA/FDA standards to reduce delays and rework.
Maintain patient safety by providing clear and consistent translation for labels in every language and region, while addressing cultural and linguistic differences.
IQVIA’s Multilingual Labelling Solutions help regulatory teams manage translations of SmPCs, PILs, and packaging content across markets. We ensure alignment with EMA, FDA, and local authority standards—minimizing errors, delays, and compliance risks.