Preparing documents for regulatory submission

Before a new drug can enter the market, a drug submission application must be filled 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 at this stage 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.

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 23 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

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