Biotechnology Translation Services

• Safety Data Sheets (SDS) GHS-compliant SDS translation for all markets. Hazard statements, precautionary statements, and regulatory information translated accurately for each jurisdiction.
• Clinical Trial Documentation Protocols, informed consent forms, patient diaries, case report forms — consistent translation across all trial sites and languages.
• Regulatory Submissions CTD modules, briefing documents, responses to regulatory questions — documentation that meets the standards of EMA, FDA, and national authorities.
• Product Labelling Primary and secondary packaging, patient information leaflets, SmPCs — compliant labelling for every market.
• IFUs and Instructions Instructions for Use for diagnostic devices, laboratory equipment, and medical instruments.
• Marketing & Commercial Materials HCP materials, patient education, website content — compelling content that meets regulatory requirements.

Biotechnology documentation errors have regulatory and commercial consequences:

• EMA/FDA rejection — Regulatory submissions with translation errors or inconsistencies delay approvals and damage credibility with authorities.
• REACH non-compliance — SDS errors in EU markets trigger enforcement action and market access problems.
• Clinical trial issues — Inconsistent informed consent forms or protocol translations create compliance and ethical concerns.
• Market authorisation delays — Documentation deficiencies hold up product launches with significant commercial impact.
• Patient safety — Unclear instructions or mistranslated safety information can affect patient outcomes.

• Regulatory precision — We understand EMA, FDA, and national authority requirements.
• MedDRA alignment — Clinical terminology translated consistently with standard medical dictionaries.
• SDS expertise — GHS-compliant Safety Data Sheets for all markets.
• Confidentiality — NDAs standard. Your clinical data, regulatory strategies, and commercial information protected.
• Global reach — 280+ languages for worldwide market access.

• Clinical trials: – Protocols and amendments – Informed consent forms – Patient diaries and questionnaires – Case report forms – Investigator brochures – Clinical study reports
• Regulatory: – CTD modules – Briefing documents – Responses to regulatory questions – PILs and SmPCs – Labelling texts
• Safety: – Safety Data Sheets (SDS) – PSUR/PBRER documents – Risk management plans
• Commercial: – HCP educational materials – Patient support programmes – Training materials

• Regulatory understanding — We know EU MDR requirements and translate with compliance in mind.

• 24-language capability — Full EU coverage when you need it, without managing multiple suppliers.

• Terminology consistency — MedDRA alignment, controlled vocabularies, and translation memory ensure consistency.

• Quality systems — Our processes support your QMS requirements.

  Confidentiality — NDAs standard. Your clinical data and commercial information protected.