Pharmaceutical Translation Services

Novalins is a pharmaceutical translation specialist dedicated to delivering the highest standards in linguistic products, while always being on-time and within budget. Our experience in the pharmaceutical translation field enables us to provide industry-standard expertise and to adapt our processes according to the specific document requirements at every stage of the product lifecycle:

• Research & Development
• Clinical trials
• Regulatory affairs
• Post-marketing surveillance
• Corporate & marketing
• Training

Novalins possesses a wealth of knowledge in the translation of pharmaceutical Product Information (SmPC, Labelling and PIL) in all European languages, complying with the procedures for MAAs (Centralised, Decentralised, Mutual Recognition, and Referral Procedures) and Variations (Type IA/IB and Type II Variations).

Novalins has an extensive network of over 3000 professional medical translators and editors who specialise in pharmaceutical translation covering 120 languages.

Our medical translators and editors are carefully selected on a project basis according to their linguistic and technical skills, experience in the area of specialisation, as well as their knowledge of regulatory requirements (EMA/FDA/Japan) and standards in the target countries. All experts allocated to every pharmaceutical translation project meet a minimum criteria:

• Native speakers of the target language with perfect command of the source language
• Extensive linguistic, scientific and medical background (M.A., M.S., PhD, MD)
• Certified medical translators by recognised bodies
• Familiar with authorities’ requirements, guidelines and templates (e.g. ICH, EMA)
• Access to standardized terminology databases and dictionaries (e.g. EDQM, medDRA)

Novalins offers our clients full transparency on the experience and qualifications of the medical translators and editors who work on their projects.

Novalins offers comprehensive pharmaceutical translation services that includes all documents produced at all stages of the drug life-cycle including:

• Registration dossiers for medicines
• Summary of Product Characteristics (SmPC), Annex II, Labeling, Patient Information Leaflet (PIL), and Annex A
• Patents and patent applications
• Clinical study protocols
• CMC documentation
• Packaging and labelling
• Patient reported outcomes (PROs)
• Informed consent forms (ICFs)
• Study protocols
• Case report forms (CRFs)
• Global value dossier

In addition to pharmaceutical translation services, Novalins also offers:

• Medical writing
• Medical transcription
• Clinical trial translation
• Linguistic validation of Patient Reported Outcomes
• Readability user testing of PILs
• Back translation
• QA/QC control – Source & target text editing by SMEs and native speakers
• Data entry (CRFs)
• QRD-compliant translations
• Mock-up creation
• Update & Variation
• Linguistic consultancy
• Sworn – Certified translation
• Translation memory management
• Terminology database management
• Page formatting (DTP) and layout preparation

Please contact us for a complete list.

Novalins understands the sensitivity of pharmaceutical documents and all our medical translators and experts work under binding non-disclosure agreements. We are also open to any additional confidentiality arrangements requested by our clients