Regulatory Affairs Expertise
Translating product materials accurately is our number one priority.
We understand the critical need for 100% accuracy and consistency when translating pharmaceutical product information, 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.
Pharmaceutical product information is vital to the safety of patients, and important to the medical professionals who inform patients about product characteristics, usage, and effectiveness. Translating product materials accurately is our number one priority. Our industry specialization, regulatory knowledge and terminology expertise ensures it is always done correctly and on time.
We are experts in analyzing pharmaceutical product documents, including:
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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 translation conducted by two highly qualified linguists, multilingual multimedia production, an additional quality control edit, final pre-production review, in-country review and certification.