Landoor, the go-to agency for Regulatory Affairs

Regulatory affairs is a complex process involving multiple professionals with different expertise – technical, scientific and administrative. Regulatory affairs experts must have perfect knowledge of national, European and international regulations, which are often drafted in languages other than Italian. In addition, an integral part of pharmaceutical industry research is the drafting of scientific documentation which usually needs translating in one or more foreign languages. Landoor is the go-to agency for regulatory offices thanks to its team of professionals specialised in the translation of documents to be submitted to health authorities as well as the translation of publications of said authorities and reports required by the Italian Medicines Agency (AIFA). When it comes to the sale and marketing of drugs, for pharmaceutical companies Landoor represents an expert partner in the translation and localisation of all scientific and administrative documentation, such as forms and applications for obtaining and maintaining authorisations from the relevant institutions.

Translation of pharmaceutical documents for government bodies

Any translation in the pharma area (documents for or issued by government bodies or official texts on recently approved drugs) must be entrusted to mother tongue translators with dual specialisation in the pharmaceutical and regulatory sectors. To guarantee both exacting quality controls and strict compliance to all relevant procedures and regulations, these professionals are always supported by revisers with expertise in both linguistics and the subject matter. Landoor translates reports by the Italian Medicines Agency (AIFA), drug use guidelines, drug safety magazines and high-profile scientific publications such as the “Relazione sullo stato sanitario del Paese” (‘Report on the state of health of the country’, RSSP) and the “Quaderni del Ministero della Salute” (‘Department of Health Notebooks’), supplementing the translations with accurate localisation work (for example, adapting the names of the drugs to the target country).

Translations for pharmaceutical companies, from dossiers for marketing authorisation to medication package inserts

Landoor works alongside the regulatory offices of pharmaceutical companies to provide linguistic and editorial support for all activities connected with marketing authorisation applications to the relevant institutions. These activities include drafting and updating medication package inserts (with quality control taking account of standards established by individual pharma companies) and ensuring the consistency of the text on the package. Landoor is also a leading provider of sworn Italian-German bilingual translations of medication package inserts and related FIT forms for the sale of drugs in Alto Adige. The translation process also includes a specific product localisation service involving the adaptation of the artwork to the design and image of the packs and to all other formal aspects requested by the database organisation (Unifarm). Landoor sends PDFs of the FIT forms directly to the pharmaceutical companies so they can be uploaded on the Unifarm online platform, which can be accessed by pharmacies in the province of Bolzano.

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Case history

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