Regulatory Documents Translation
Precision in Compliance
At Translate.One, we provide extensive regulatory translation solutions designed to streamline the international compliance process, facilitating accurate and timely submissions. Our clients trust us for our regulatory expertise and ISO-certified processes, as we ensure translations that are not only linguistically precise but also align with local and cultural requirements seamlessly.
With over 25 years of experience, we have been a reliable partner to global pharma, medical device, biotechnology, CRO, and healthcare organizations, helping them overcome regulatory obstacles. We specialize in preparing documentation for various governing bodies worldwide, including but not limited to the FDA, EMA, CFDA, SFDA, and PMDA.
We Handle a Broad Range of Regulatory Documents
Our specialization extends across various domains within the medical industry, including:
- Instructions for Use (IFUs)
- Investigator’s Brochures (IBs)
- Labeling
- New Drug Application (NDA) or Marketing Authorization Application (MAA)
- Package Information Leaflets (PILs)
- Summary of Product Characteristics (SmPC)
- Common Technical Documents (CTD)
- Technical File (TF) or Design Dossier (DD)
- Clinical Study Reports (CSRs)
- 510(k) Submission
- Premarket Approval (PMA) Application
- Post-Market Surveillance (PMS) and Vigilance Reports
- Quality Management System (QMS) Documentation
- Dossiers
- Validation Documents
- Chemistry, Manufacturing & Control Documentation (CMC)
What Makes Our Services Stand Out
Why Us?
Industry-Compliant Translations
We understand that each sector has its unique set of regulatory challenges. Our linguists not only master multiple languages but are also well-versed in industry-specific regulations, ensuring compliance on a global scale.
ISO Certified Processes
We are proud to uphold ISO 9001, 17100, and 13485 certifications, reflecting our commitment to quality, customer satisfaction, and adherence to the highest standards in translation services.
Confidentiality and Data Security
Your regulatory documents are sensitive, and we treat them with the utmost confidentiality. Our secure ISO 27001 certified systems and our adherence to data protection protocols provide you with peace of mind.
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What Our Clients Have to Say
At Translate.One, our clients’ satisfaction is our utmost priority. We take pride in delivering exceptional translation services that exceed expectations. But don’t just take our word for it – hear what our clients have to say.
