Regulatory Documents Translation
Precision in Compliance: Elevate Your Global Reach with Expert Regulatory Translations
At Commit Global, we provide extensive regulatory translation solutions designed to streamline the international compliance process, facilitating accurate and timely submissions. Our clients entrust us for our regulatory prowess 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 steadfast partner to global pharma, medical device, biotechnology, CRO, and healthcare organizations, aiding them in surmounting 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
- Instructions for Use (IFUs)
- Labeling
- Package Information Leaflets (PILs)
- Common Technical Documents (CTD)
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- New Drug Application (NDA) or Marketing Authorization Application (MAA)
- Summary of Product Characteristics (SmPC)
- Technical File (TF) or Design Dossier (DD)
- 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)
Why Choose 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.
