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Regulatory Translation

Regulatory compliance is the key to acquiring product licenses and the cornerstone to access new markets. The regulatory translation is the translation of documentation on the approval and compliance of medical devices, pharmaceuticals and in vitro diagnostics products. From chemical to manufacturing, medical device to clinical research, healthcare to pharmaceutical, MedTrans offers high-quality regulatory translation services to meet regulatory compliance worldwide. Our experience and expertise will help you ensure your medical documents are approval-ready and meet the local regulatory standards with all language requirements.

Regulatory documents include (but are not limited to):

  • Manufacturing procedures for drugs
  • Design specifications and drawings
  • Risk assessments
  • CMC documentation
  • Bio-compatibility reports
  • Regulatory approval dossiers
  • Clinical trial documentation – informed consent forms, case report forms, protocols
  • Instructions for Use for drugs or medical devices
  • Patient Reported Outcomes Forms (PROs)
  • Medical Device Directive (MDD)
  • In-Vitro Diagnostics Directive (IVDD)

Overview of some well-known international regulations that require translation services.

  • CE Marking Translation
  • MSDS Translation
  • Title 21 CFR Part 11 Translation
  • Section 508 Compliant Translation and Localization
  • DOT and FTA Title VI and Circular 4702.1B Translation

Translation and Submission Workflow

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Preparatory services for regulatory submission
Risk/therapeutic product category classification
Registration requirement
Regulatory strategy
Roadmap planning

Execution of regulatory submission
Gap assessment
CTD development
Adaption & organization of submission justifications
Pharmaceutical and medical device registration
Regulatory submission and liaison
Adaptation of packaging artwork and leaflet

Post launch regulatory support and compliance
Advisory on post-launch lifecycle compliance
Drafting of post-approval communications

Our Team

Extensive industry experience of working with regulatory agencies like FDA, EMA, CFDA, and PMDA.
Serving companies in Healthcare, Pharmaceutical, Biotech, Medical Devices, and more.
Specific knowledge of the document templates required for different countries' dossier formats.

Quality Policy

ISO 17100 and ISO9001 certified processes
All foreign language translations can be certified as complete and accurate if necessary (as is the case in the US).

A successfully constructive translation enables a pharmaceutical business to achieve faster approval for its medical and health products. Partner with MedTrans when your content has to be right, in any language and any market. Sensitive documents will be translated correctly and maintain regulatory compliance.

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