To deliver a translation that met Lenis’s standards and complied with EMA guidelines, we implemented a thorough, multi-step approach.
Lenis, a pharmaceutical company dedicated to delivering high-quality healthcare solutions, recently reached out to us for translation services involving critical medical documentation.
These documents, including the Patient Information Leaflet (PIL) and Summary of Product Characteristics (SmPC), are not only essential for regulatory compliance but also play a vital role in ensuring patients and healthcare providers have access to accurate information.
As these documents were intended for a Slovenian audience, we were tasked with translating them from German (DE) to Slovenian (SL) according to the European Medicines Agency’s (EMA) Quality Review of Documents (QRD) template.
This translation project was particularly sensitive and complex, as medical content demands absolute accuracy and consistency, with no margin for error.
The QRD template, designed by the EMA, provides specific language, phrasing, and formatting guidelines to standardize medical documentation across different languages within the European Union.
For Lenis, this meant that every translation needed to align precisely with the QRD template while remaining both accurate and clearly understandable.
Ensuring Complete Consistency with the QRD Template – Both language and formatting needed to align with the QRD template to comply with EMA standards.
Delivering a High-Quality, Precise Translation – Medical content is highly specialized, requiring technical expertise and a deep understanding of pharmaceutical terminology in both German and Slovenian.
Maintaining Formatting Consistency – In addition to linguistic consistency, formatting needed to match the QRD standards to ensure readability and regulatory approval.
The translation of PIL and SmPC documents presents unique challenges due to the technical and legal requirements involved. Medical documentation, unlike general content, is governed by strict regulations to ensure clarity and avoid any potential misunderstanding by patients or medical professionals.
Absolute Accuracy: Inaccuracies in translation could lead to severe consequences, such as misinterpretations of usage, side effects, or dosages.
Template Consistency: The QRD template’s formatting and phrasing are non-negotiable; even minor deviations can lead to compliance issues.
Specialized Terminology: Medical documents require the translator to have a deep knowledge of pharmaceutical language and healthcare-specific terms in both the source and target languages.
In our work with Lenis, these challenges were compounded by the need for absolute precision and the need to match the exact format and language prescribed by the EMA’s QRD template. Each sentence, phrase, and even punctuation mark required careful scrutiny.
To deliver a translation that met Lenis’s standards and complied with EMA guidelines, we implemented a thorough, multi-step approach. This included terminology alignment, translation, review, quality assurance (QA), and desktop publishing (DTP).
Since the QRD template is the cornerstone of the EMA’s regulatory standards, we began with an alignment process to extract necessary terminology from the template.
This involved aligning both the English (EN) and Slovenian (SL) QRD templates to ensure that all phrases were accurately matched. By creating a specialized glossary, we ensured that our translators could use standardized phrases and terminology consistently across all documents.
This alignment stage was invaluable in establishing a linguistic foundation for the project, ensuring that no deviations from the approved EMA language could occur during translation.
With this glossary in place, we could move forward confidently, knowing that every term and phrase matched the EMA’s approved language.
With our glossary established, our specialized translation team began the initial translation process. Our team consisted of linguists with expertise in pharmaceutical content, ensuring that the translation maintained both accuracy and the technical precision required by the QRD template.
Once the initial translation (TRA) was complete, the document underwent a rigorous review (REV) by a senior linguist with further experience in medical translations.
The goal of this review was to double-check terminology, grammatical accuracy, and the overall flow of the document. This dual-layered approach allowed us to catch and correct even the smallest inconsistencies, upholding the accuracy needed for compliance with the EMA standards.
After the translation and review stages, the document underwent an internal quality assurance (QA) process.
In this phase, we focused on the finer details, verifying the consistency of terms, reviewing formatting alignment with the QRD template, and confirming that the translated text accurately conveyed the content of the original German document.
This stage was essential for medical translations, where accuracy is paramount, as even minor errors could have significant consequences. Our QA team ensured that the document not only met Lenis’s standards but also complied with all regulatory guidelines.
After ensuring linguistic and terminological accuracy, we moved to the final stage of desktop publishing (DTP). The QRD template requires specific formatting standards that must be strictly followed for regulatory approval.
This DTP phase ensured that every aspect of formatting – from line spacing and paragraph alignment to text font and structure – was in line with the QRD template.
Using a single team for translation, review, and DTP allowed us to maintain a high level of consistency throughout the entire process, enabling us to finalize a document that was both accurate and format compliant. This consistent team approach meant that every stage built on the previous one, reducing the chance of miscommunication or errors in formatting.
The result of our work was a set of Slovenian PIL and SmPC documents that not only met Lenis’s expectations but also adhered rigorously to the QRD standards. Through our multi-step translation process, we delivered a final product that offered:
Complete QRD Template Compliance: Our adherence to the QRD template in both language and formatting ensured that Lenis could confidently submit the documents for regulatory approval.
Accurate and Consistent Pharmaceutical Terminology: The glossary created during our alignment stage allowed us to maintain consistency in specialized terminology, a critical factor for clarity and regulatory success.
Enhanced Quality Control and Reliability: Our dual-layered review process, followed by rigorous QA, minimized the risk of errors, ensuring that the content was accurate and error-free.
This meticulous process allowed us to meet Lenis’s needs for a precise and professional translation, ensuring that all medical information was accurately conveyed in Slovenian, with no room for misinterpretation.
The translated documents not only met regulatory standards but also provided patients and healthcare professionals with reliable, clearly understandable information.
Our translation services, specifically our approach to handling QRD-compliant documents, set us apart for a few key reasons:
Specialized Team for Medical Content: Our translators and reviewers have expertise in pharmaceutical content, which is essential for producing translations that meet stringent standards.
Attention to Detail and Template Compliance: Our rigorous QA and DTP processes ensure that every translated document is format-compliant and ready for regulatory submission, with no need for further adjustments.
End-to-End Consistency: By using the same team for every step of the process, from translation to final formatting, we ensured that the project’s consistency and accuracy were maintained throughout.
For pharmaceutical companies like Lenis, translation accuracy in PIL and SmPC documents is crucial for regulatory compliance and patient safety. Our comprehensive translation services ensured that Lenis received QRD-compliant documents in Slovenian, complete with accurate terminology and formatting.
Through alignment, translation, review, QA, and DTP, our team delivered a final product that met all requirements, demonstrating how meticulous translation services can ensure both regulatory success and a clear, accurate presentation of essential healthcare information. This project highlights our commitment to delivering high-quality translations for the pharmaceutical industry, where precision is not just expected – it’s essential.
Turizem Bled
Deutschfuchs
Huppenkothen
Inventio
Mercator
Ljubljanske Mlekarne
Vistream
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