Services
Specialised Language Support for Regulated Life Sciences Content
NN Translations provides specialised translation for clinical, pharmaceutical, regulatory, medical device and patient-facing content across more than 200 languages. Our services are delivered within an ISO 9001 and ISO 17100 certified quality framework.
We support clinical trial sponsors, Contract Research Organisations (CROs), COA licensing companies, eCOA providers, pharmaceutical and biotechnology companies, and medical device and IVD manufacturers with language workflows adapted to the content, intended audience, regulatory context and project requirements.
Our focus extends beyond linguistic accuracy to terminology consistency, clarity, cultural appropriateness and controlled documentation, with workflows adapted to the regulatory context, intended audience and requirements of each project.
Specialist Areas
Translation support for:
Patient-Reported Outcome (PRO)
Clinician-Reported Outcome (ClinRO)
Observer-Reported Outcome (ObsRO)
Performance Outcome measures (PerfO)
When a COA is translated or adapted for use across languages and target populations, we manage it through our dedicated Linguistic Validation workflow to support conceptual equivalence, cultural appropriateness and the collection of comparable clinical outcome data.
Study documentation and materials used by clinical teams, sites and participants, including:
clinical trial protocols and protocol synopses;
informed consent forms and participant information;
investigator and site materials;
clinical study reports;
safety communications;
training and study support materials
We provide specialised translation for IFUs, labelling, patient-facing materials, clinical and regulatory documentation, and other medical device and IVD content.
Projects requiring source-content preparation can also include IFU Content Optimisation and Regulatory Support, delivered where appropriate in collaboration with experienced regulatory affairs consultants.
Content we support includes:
Instructions for Use, product manuals and user guides;
labelling, packaging and patient-facing materials;
technical documentation and regulatory submissions;
Clinical Evaluation Reports, Performance Evaluation Reports and safety documentation;
clinical investigation documentation and study materials;
Summary of Safety and Clinical Performance documents;
post-market surveillance and vigilance documentation;
quality management and manufacturing documentation;
product training and eLearning materials; and
scientific, technical and market-facing product content
Where required, medical device projects can also be coordinated with usability testing through experienced specialist partners, including evaluation of user-facing information in the intended-use context.
Specialised translation for pharmaceutical, biotechnology and regulatory workflows, including:
product information and labelling;
Summaries of Product Characteristics;
Patient Information Leaflets;
regulatory correspondence and submission content;
safety and pharmacovigilance documentation;
quality and manufacturing documentation;
medical and scientific communications
For Patient Information Leaflets, we can also coordinate Readability Testing of PILs and, where appropriate, bridging evaluation and related testing strategies through experienced specialist partners.
Resources
Access practical guidance and supporting materials across our specialist areas.
Contact us with your content type, source and target languages, intended audience, expected word count, reference materials and required timeline.