Pharmaceutical Translation Services

Regulatory translation demands more than language expertise — it requires complete familiarity with global compliance frameworks and submission standards. LingArch’s professional pharmaceutical regulatory translation services support every stage of your product lifecycle, ensuring your documents are regulator-ready across multiple markets.

• Clinical Trial Applications (CTAs)
• Common Technical Documents (CTD)
• Product Information Leaflets (PILs)
• Summary of Product Characteristics (SmPCs)
• Regulatory submissions for MHRA, EMA, and FDA
• Documents aligned with ICH E3, E6, and M4 requirements
• eCTD-ready formatting support

Using advanced translation memory tools and terminology management systems, we maintain consistency, precision, and version accuracy across all documents — even in the most complex regulatory environments.

Types of Pharmaceutical Documents We Translate

Our expert team translates a wide range of technical, scientific, and regulatory documentation, including:

• Clinical research reports and drug trial protocols
• Investigator brochures and pharmacovigilance reports
• Informed consent forms and patient information leaflets
• Labelling, packaging inserts, and product monographs
• Manufacturing SOPs and quality control documentation
• Medical device manuals and compliance certificates
• Adverse event reports and safety summaries

We support pharmaceutical companies, contract research organisations, biotech firms, hospitals, and research institutions worldwide — providing compliant documentation in 120+ languages.

For legal and intellectual property needs, LingArch also supports patent translation for pharmaceutical and biotechnology submissions.