Regulatory pharmaceutical translation
Trans-Edit Group: the partner for Regulatory Affairs Managers
The pharmaceutical industry’s constant research into therapeutic solutions to improve patients’ lives requires copious drafting of scientific papers which are often translated into one or more languages.
Translating documents for government institutions, such as AIFA (the Italian Medicines Agency) reports, constitutes a substantial part of TEG's work.
In turn, the production of drugs by pharmaceutical companies requires TEG’s direct involvement in the translation of scientific and administrative documents aimed at obtaining and maintaining licenses from relevant authorities, such as AIFA in Italy.
Pharmaceutical translations for government institutions
All translations for the pharmaceutical sector – particularly documents intended for or issued by government bodies and those relating to the process of drug approval – require the use of native translators specialized in the medical and pharmaceutical industries, as well as in regulatory affairs. Our professionals, working as a team with language revisors and consultants, combine their expertise with rigorous quality control, in compliance with current procedures and regulations.
TEG translations encompass AIFA reports, pharmaceutical product instructions, pharmacovigilance magazines and important scientific publications such as the "National health service report" and the "Notebooks" of the Ministry of Health.
Translations for pharmaceutical companies, from dossiers for marketing authorization to information leaflets
TEG works closely with pharmaceutical companies’ regulatory departments, supporting them with all necessary linguistic and editorial work when submitting a dossier to government authorities to obtain marketing authorization (MA).
This work includes drafting and regularly updating patient information leaflets, which require translation and quality control in compliance with the specific standards of individual pharmaceutical companies, and the standardization of the package.
Certified translations of bilingual information leaflets for South Tyrol and relevant FIT forms account for a major part of TEG’s work in this area. TEG undertakes a true localization in this particular case, adapting artwork to the correct format, the appearance of the package and any other formal aspect required by the local management authority (Unifarm). Pharmaceutical companies can thus receive FIT forms in suitable PDF format directly from TEG, ready for immediate uploading to the Unifarm database accessed by pharmacies in South Tyrol.