About Us

A Boutique Life Sciences Partner

NN Translations is a boutique life sciences business outcomes partner supporting clients at key stages of clinical research, Clinical Outcome Assessment (COA) and medical device regulatory content.

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Established in 2010, NN Translations has evolved from an English–Bulgarian translation practice into an international life sciences partner coordinating Linguistic Validation, COA/eCOA services and regulated content projects across more than 200 languages.

Our People

The People Behind NN Translations

Without our people, NN Translations simply wouldn't be the same.

We believe that strong outcomes depend on recognising and respecting everyone involved in the process and the expertise and contribution they bring. From our clients and project teams to clinical and regulatory specialists, linguists, clinicians, patient associations and the patients themselves, every perspective has its place.

The best outcomes come from balance – when everyone involved is given their place, their voice and the respect their contribution deserves.

Specialist Areas

Our Focus

Our work is centred around two specialist areas: clinical research and patient outcomes, and medical devices and IVDs.

Across clinical research, we support clinical trial sponsors, CROs, COA licensing companies and eCOA providers with COA Planning & Consulting, COA Licensing & Management, Linguistic Validation, eCOA Migration & Support, and the translation of wider clinical trial documentation.

For medical device and IVD manufacturers, we provide specialist support across IFU content Optimisation & Regulatory Support, Medical and Regulatory Translation, and Readability & Usability Testing.

In both areas, our role is to bring together the right linguistic, clinical, regulatory and project expertise within one coordinated quality framework.

Why NN Translations

Why Clients Choose Us

A Specialist COA Ecosystem

We bring together clinical trial professionals, COA strategy and licensing consultants, instrument developers and copyright holders, eCOA providers, in-country Linguistic Validation Consultants, specialised translators, clinicians, regulatory and scientific specialists, and patient-association partners supporting participant recruitment.

This allows each project to be structured around the instrument, study design, target population, mode of administration and applicable requirements.

One Coordinated Quality Framework

Our quality management system is certified to ISO 9001 and ISO 17100, supporting specialist selection, controlled project management, linguistic quality assurance, traceability and continuous improvement.

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Our methodologies are informed by recognised guidance and applicable frameworks, including relevant ISPOR and ISOQOL good practices and recommendations, FDA and EMA guidance relevant to COA and Linguistic Validation, and EU MDR, IVDR, MHRA and FDA requirements and guidance relevant to medical device documentation.

Leadership

Our Founder

Nataliya Nedkova is the Founder and Managing Director of NN Translations, a certified Linguistic Validation Consultant (LVC) and a member of the International Society for Quality of Life Research (ISOQOL). She has more than 11 years of linguistic validation experience and over 16 years of expertise in life sciences translation and international project coordination.

Case Studies

Selected Client Outcomes

Clinical Research

COA Linguistic Validation Case Study

Challenge: Linguistic Validation of PRO measures across 15 languages for diverse patient populations, including Huntington's disease, Crohn's disease, Sjögren's disease, systemic sclerosis and rheumatoid arthritis.

Approach: Translation availability and LV gap assessment, concept-focused forward and back translation, clinician review, disease-specific participant recruitment and Cognitive Debriefing by native-speaking LVCs.

Outcome: Assigned LV stages completed within scope and timelines, with documented linguistic decisions, Certificates of Linguistic Validation and population-specific considerations escalated early.

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Medical Devices

MDR Translation for 11 European Markets Case Study

Challenge: Deliver an IFU and patient leaflet for CE marking in 11 European markets under a tight deadline, coordinating 22 medical device linguists while maintaining terminology consistency and traceability.

Approach: We established dedicated translator–reviser teams and followed ISO 9001- and ISO 17100-certified processes covering independent revision, terminology harmonisation, source review, local stakeholder feedback and final QA.

Outcome: All 11 language versions were delivered on time with consistent terminology and documented traceability. The client received fully reviewed and approved content ready for regulatory use.

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Resources