Translation for regulatory submission-pharmaceutical translations.

Before a new drug can enter the market, a drug submission application must be filed with the relevant regulatory agency for review and approval.
Within the European Union a marketing Authorization Application should be launched via the centralised procedure required by the EMA (The European Medicines Agency).

A high-quality English draft should be produced by the applicant and enough time should be allowed for an equally high-quality translation to be produced by the partner translation agency into all 23 official languages of the EU.
The three main types of documents required for translation for regulatory submission are:

  • Product Information Leaflets

  • Labelling

  • Summary of Product Characteristics

It is very important for pharma producers and CROs to chose reliable translation partners with specific expertise in the pharma and regulatory affairs fields.

PHARMA TRANSLATION SERVICES – for private pharma companies, CROs, and regulatory bodies (such as EMA, ECHA etc)

Paspartu assists Marketing Authorization Holders, medium-sized and major drug producers in Europe in translating their new pharma products into all European languages for marketing authorization purposes.

SmPC, labelling, and package leaflets are some of the main documents required by the EMA (European Medicines Agency) when a company applies for marketing authorization of a new medicine.

The English translation of these documents is reviewed by the EMA in the so-called pre-opinion phase. Drugs approval/ rejection decisions, recommendations for use, standard operating procedures as well as various scientific reports are other types of documents commonly translated by Paspartu’s dedicated medical team, in the context of EMA related projects.

Are you preparing any drug products for the EMA centralized approval procedure? Let’s talk best translation tactics for SmPC, PIL and Labelling, for national, MR, DC or centralized procedures!

This is what Paspartu Translation Services, through its specialised Pharma & regulatory affairs department, can do for you:

  • Perform a readability testing on your PILs, to ensure that the content can be read and understood by lay patients; draft a report on any suggested changes that should be implemented in the source file, as this is a legal requirement of EMA for certain categories of medicines in Europe

  • Translate your English draft into the 24 EU languages within the required deadline

  • comply thoroughly with your instructions regarding QRD templates to be used, file naming conventions, linguistic preferences and reference material

  • apply specific translation memory technology to identify repeated content and render terminology consistently

    Check our translation projects with leaders in pharma and medical technology here-

Translation and linguistic validation