At Intertranslations, we are committed to maintaining the highest standards in pharmaceutical translations. One of our key initiatives in achieving this commitment is our Linguistic Review process, a pivotal step in ensuring the accuracy and consistency of translations within the framework of the European Medicines Agency (EMA)’s centralized Marketing Authorization (MA) application procedure.
The Significance of Linguistic Review
The pharmaceutical sector demands meticulous attention to detail and precision in translations, where even the slightest error can have serious consequences. Our Linguistic Review process encompasses several essential elements to guarantee the utmost quality in pharmaceutical translations.
1. In-Depth Source Text Analysis
Our process begins with a thorough analysis of the source text. This step allows us to fully comprehend the content’s context and domain. To ensure consistency and accuracy, we employ comprehensive terminology databases and glossaries.
2. Expert Linguist Selection
Our team of linguists is not only composed of language experts but also specialists in medical and regulatory terminology. We carefully assign translators based on their specific expertise, whether it’s cardiology, neurology, or other specialized fields, minimizing errors and enhancing translation accuracy.
3. Adherence to Quality Review of Documents (QRD)
We strictly adhere to Quality Review of Documents (QRD) templates when translating critical documents. This commitment ensures uniformity and regulatory compliance. Our translation tools are equipped with up-to-date QRD templates, streamlining the translation process and focusing on newly added or modified content.
4. Utilizing EMA Resources and Guidelines
Our process aligns with EMA’s resources and guidelines, including MedDRA and IATE. These valuable resources are integrated into our terminology databases, harmonizing our translations with approved medicinal products, maintaining consistency, and preventing discrepancies.
5. Rigorous Quality Control
Our quality control measures include additional revisions and proofreading to identify and rectify any discrepancies. For complex segments, we employ Language Quality Inspection (LQI), ensuring our final translations meet the highest linguistic quality standards.
6. Effective Communication
Facilitating effective communication between Marketing Authorization (MA) applicants and Member States is vital. We address queries and incorporate feedback into the Linguistic Review process, enhancing the accuracy and quality of translations.
7. Precise Document Formatting and Layout
In the final stages, we meticulously format all translated documents in accordance with regulatory guidelines. Our translation software helps maintain consistency with the source files, and we conduct a thorough visual check before finalizing the documents.
Our Commitment to Excellence
With over two decades of experience in pharmaceutical translations, Intertranslations understands the complexities of regulatory compliance in the pharmaceutical sector. Our extensive network of specialist translators and subject-matter experts, combined with cutting-edge technology, guarantees translations of the highest quality. We are unwavering in our dedication to accuracy, consistency, and confidentiality, consistently meeting the stringent requirements of pharmaceutical translations.
If you require a pharmaceutical translation agency that excels in exceptional quality and premium services, our team of pharmaceutical translation specialists at Intertranslations is here to assist you. Contact us today to learn how we can elevate your pharmaceutical translation needs to the next level of excellence.
