Regulatory Translation Services

Novalins is a regulatory translation specialist dedicated to delivering high-quality translations to clients around the world, always on-time and within budget. We have many years of experience working with regulatory documents including CTD dossiers, SmPCs, labelling, PILs, validation protocols, and Instructions for Use.

EMA Submissions

Novalins possesses a wealth of experience in the translation of Product Information required by the EMA for MAAs for both human and veterinary medicinal products. To date we have successfully translated hundreds of QRD-compliant translations in all EU languages for different drug approval procedures – Centralized Procedure (CP), Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), Referral Procedure, Type IA/IB and Type II Variations.

We collaborate with experienced project managers and a strong network of medical translators who specialise in regulatory translations and are familiar with the guidelines of EMA (such as QRD formats) and the requirements of national authorities. The synergy between our team members enables us to provide high quality translations within the required timeframe.

Novalins has a large network of over 3000 medical translators and editors who specialised in regulatory translations in all major languages. All of our experts meet a minimum criteria of:

• Native speakers of the target language with a perfect command of the source language
• Extensive linguistic, scientific and medical background (MA, MS, PhD, MD)
• Certified medical translators by recognised bodies
• Regulatory documents experts and familiar with regulatory guidelines and templates
• Access to standard terminology databases such as EDQM termbase, 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 regulatory translation services that cover all documents involved in the registration process. The most frequently translated documents include:

• Marketing Authorisation Dossiers – CTD module 1, CTD module 2, CTD module 3, CTD module 4 and CTD module 5
• Summary of Product Characteristics (SmPC)
• Patient Information Leaflet (PIL)
• Packaging and Labelling
• Validation protocols
• Expert reports
• Instructions for Use

In addition to regulatory translation, Novalins also offers the following services:

• Round 2 (CHMP update) and Round 3 (handling of linguistic comments) of changes
• Generation of PDF versions of the PI
• Updates (Type Ia/Ib and Type II Variations to existing Marketing Authorisations)
• Updates of PI according to the latest QRD templates
• Implementation of blue-box requirements
• Mock-up creation
• Medical Writing
• Medical transcription
• Clinical translation
• Medical language translation
• Readability testing

Please contact us for the complete list of solutions we offer.

Novalins understands the sensitivity of regulatory affairs 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.