If your pharma or clinical trial documentation goes through translation without strict control, you risk audit failures, regulatory pushbacks, or even trial delays. We specialize in precise, compliant translation for pharma companies and CROs who demand zero room for error.
Expert Team with Pharma & Regulatory Focus
Our linguists don’t just speak languages — they understand pharma regulations, clinical protocols, and compliance requirements like FDA, EMA, and ICH guidelines. Every project gets a dedicated specialist who’s worked with IFU, protocol amendments, dosage sheets, and clinical trial reports.
Proven Processes & Quality Standards
We follow ISO 17100 and maintain rigorous QA cycles, including terminology management and multi-stage review workflows. NDA and data privacy agreements ensure your sensitive clinical data stays confidential. Each translated document has a complete audit trail for compliance verification.
Technology that Supports Compliance
Using specialized CAT tools, TM systems, and secure portals, we handle complex file formats including XML and PDF locked files common in pharma. Terminology databases and style guides are updated continuously to avoid inconsistencies that auditors will flag.
Regulatory & Security Guarantees
We guarantee compliance with HIPAA, ITAR, and other data protection regulations. SLAs cover turnaround times and quality benchmarks tailored to pharma timelines — so you can avoid costly trial delays or regulatory rejections.
Real-World Example
A mid-size pharma company outsourced their clinical trial protocol translation to an unvetted provider and faced FDA audit issues due to inconsistent terminology and missing traceability. After switching to our service, they passed all subsequent audits without comments, with faster review cycles and less back-and-forth.
How We Work & Pricing
We offer scalable service models: from single protocol translation to full trial document packages. Transparent pricing with clear SLA options. Fast-track turnaround options available for urgent regulatory deadlines.
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