Corporate Translations

Translation Moves Drug Submissions Forward

REGULATORY AFFAIRS

Translating your product materials accurately is our number one concern. Our industry specialty, regulatory knowledge and terminology expertise assures it’s always done correctly and on time.

  • Regulatory Affairs Experts
  • Risk Management
  • Submissions Translation Advisors

Pharmaceutical Translations to Ensure Compliance and Safe Outcomes

Pharmaceutical product information is vital to the safety of patients, and important to the medical professionals who inform these patients about product characteristics, usage, and effectiveness. We understand the critical need for 100% accuracy and consistency when translating pharmaceutical product information such as packaging, SmPCs, prescribing information, medication guides, product monographs, patient information leaflets and other related materials.

We fully understand the serious ramifications associated with these documents. Therefore we not only follow the regulated processes for conducting the translation of these materials, but we have also developed our own augmented quality control measures to ensure the highest quality available.

Regulatory Document Types Translated

Our exclusive focus in translating documentation for the life science industry has made us experts in analyzing each of your pharmaceutical product documents and determining the most appropriate translation solution.

  • Packaging
  • Labeling/SmPCs
  • Package Inserts
  • Pharmaceutical Product Information
  • Patient Prescribing Information
  • Patient Information Leaflets (PILs)
  • Common Technical Documents (CTDs)
  • MSDS - Material Safety Data Sheet
  • Regulatory Correspondence
OUR METHODOLOGY

Our Methodology

We have successfully guided many international pharmaceutical companies through the regulatory requirements associated with translating pharmaceutical product information for regulatory submission and consumer use. We have also designed a number of internal standard operating procedures to dovetail with the European, Asian and U.S. regulatory bodies' requirements for document types containing this content. At a minimum, all translations containing pharmaceutical product information go through a series of highly defined steps including a translation conducted by two highly qualified linguists, multilingual mulitmedia production, an additional quality control edit, final pre-production review, in-country review, and certification.

We also adhere to the translation methods required by global regulatory authorities. For example, we have a significant amount of experience managing the translation of drug labels and SmPCs. This process begins with our intimate familiarity with the EMA’s strict requirements, its Quality Review of Documents (QRD) group and each of the 23 Member State representatives responsible for ensuring local regulatory standards are met for each language. Our understanding of global regulatory requirements in combination with our unique internal methodologies ensure that you receive compliant and accurate translations quickly.

  • 99% On-Time Delivery
  • Exceptional Customer Satisfaction
  • Less Than 2% Error Rate

QUALITY AND PERFORMANCE

Our ISO 9001:2008, ISO 13485:2003 and iso 17100:2015 Quality Management System acts as the foundation for delivering translations of unparalleled quality. Through the intelligent use of our linguistic resources, translation memory and document archives, we quickly identify related documents and ensure that they are translated quickly, accurately, and cost-effectively.

We understand the critical need for accuracy and on-time delivery for pharmaceutical product information translations. As a result, we hold ourselves accountable to unusually high key performance objectives that are monitored for effectiveness on a monthly basis.

Learn more about our translation quality and performance
LANGUAGE LIST

Language List

Corporate Translations provides translation, linguistic validation and multimedia production services in more than 100 languages, including all European, Asian, African, Middle Eastern and American languages.

View our full translation language list
Let Us Help You

We know that responding to you quickly is vital to moving your projects forward. Your request is in the hands of our experienced translation experts and you can expect a rapid response from one of our client service specialists, and a quotation in less than 24 hours.

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