Regulatory Affairs Expertise

Regulatory Affairs Expertise

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.

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. 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.

We are experts in analyzing pharmaceutical product documents, including:

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

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.

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.

Contact us for more information
+1 (860) 727 6000