Pharmaceutical Companies
Specialised Support for Pharmaceutical Companies
At NN Translations, our core expertise lies in linguistic validation and specialized life sciences translations tailored to the pharmaceutical industry. We support companies in ensuring the conceptual accuracy, cultural appropriateness, and regulatory compliance of patient-facing and clinical materials across multiple languages.
Our linguistic validation services are especially valuable for companies developing Clinical Outcome Assessments (COAs), patient questionnaires, and other essential tools required in clinical research and post-marketing studies.
In addition, we offer precise translation of regulatory documents such as SPCs (Summary of Product Characteristics), PILs (Patient Information Leaflets), and labelling, following the EMA’s QRD templates.
Our team is well-versed in navigating MeDRA and EDQM standard term databases, guaranteeing terminology accuracy and full adherence to the evolving regulatory framework. Whether for linguistic validation or regulatory translation, we ensure your documentation meets the highest quality standards for successful international submissions.
Expertise in Regulatory Compliance
Our dedication to excellence encompasses the precise translation of adverse event reports and the provision of specialised pharmacovigilance translation services. Understanding the paramount importance of these documents, we commit to delivering life sciences translations that uphold the highest accuracy and regulatory compliance standards.
Serving the Pharmaceutical Sector
We proudly offer our linguistic validation and translation services to a wide range of clients in the pharmaceutical sector, including CROs, pharmaceutical companies, and medical device companies. We aim to be your reliable partner in bridging language gaps, ensuring effective global communication, and facilitating compliance with international regulatory standards.
NN Translations provides accurate translations for a variety of pharmaceutical materials, including:
- SPCs (Summary of Product Characteristics)
- PILs (Patient Information Leaflets)
- Labeling
- Adverse Event Reports
- Regulatory Submission Documents
- Clinical Trial Protocols and Reports
- Linguistic Validation of COAs
- Manufacturing and Quality Control Documentation
- Marketing Authorisation Applications
- Pharmacovigilance Documentation
- Product Monographs
- Informed Consent Forms
- Instruction for Use
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