The daily practice of pharmaceutical regulatory affairs requires the prompt and accurate translation of several documents, thus making translation an essential part of the services needed by companies.
However, pharmaceutical companies have often neither the time nor the skills to carry out such tasks, and translation agencies are rarely qualified for the translation of scientific texts requiring specific technical terminology.
Di Renzo Regulatory Affairs can count on a unit of experts in the regulatory field, that can ensure quality and accuracy in the translation of all kinds of materials in the field of regulatory affairs, and in the pharmaceutical industry in general.
Our team is made up of professional translators, assisted by graduated experts in chemistry and pharmaceutical technology, pharmacy, biotechnology. We also avail ourselves of English, German, Spanish, Greek, and Russian native speakers.
Our professional translators are supported by up-to-date tools, such as CAT tools and translation memories to ensure consistency as well as appropriate use of terminology and true correspondence to the texts.
The submission of new marketing authorization application, variations, and renewals always provides for the inclusion of updated product information.
Thanks to high scientific competence matched to linguistic qualifications, our specialized experts can translate the Summaries of Product Characteristics and Patient Information Leaflets, taking into account the European Standards, the national requirements and the translated information already available.
The Italian legislation provides for that the labels and Patient Information Leaflets of medicinal products marketed in the bilingual area of Bolzano should also be available in German, to be delivered to German-speaking patients via the dedicated database Unifarm.
These, however, cannot be the same as those circulating in other German-speaking Member States, as they must comply with the specific legal requirements in force in Italy.
Di Renzo Regulatory Affairs avail themselves of a German native speaker, who takes care of the German translation of the labelling and PIL to be uploaded in the Unifarm database.
Regulatory documentation for registrations
The registration and maintenance of a marketing authorization includes document exchanging as well as compliance with requests and obligations from the authorities.
The translation team of Di Renzo Regulatory Affairs can promptly provide two-direction translations of deficiency letters, CA official information, cover letters, official forms and templates, that are required for the daily management of pharmaceutical procedures.
After the MA has been granted, we can support pharmaceutical companies in the translation of educational materials, scientific information materials, papers from literature and monographs supporting the product advertising of medicinal products to health professionals, as well as website texts and pharmacovigilance reports.
The registration and maintenance of a MA requires the managing and handling of a huge amount of documents, some of which must mandatorily be submitted in Italian.
Our skilled translators can take care of two-direction translations of agreements, contracts, certificates, balance sheets, memorandums and articles of association, Chamber of Commerce statements, and other documents requested by public authorities.
Some authorities request that documents originally drafted in a foreign language are also submitted in Italian via a sworn translation ensuring that the translated text is the exact and true translation of the original document.
Di Renzo Regulatory Affairs take care of sworn translation of documents at the local Court, as well as of their legalization in front of a notary, when applicable.
Clinical trial documentation
The documentation requested by Ethics Committees, investigational centres and other clinical trial authorities often involves accurate translations requiring considerable competence in specific technological and medical fields, especially when it comes to medical devices.
Di Renzo Regulatory Affairs employ qualified and specialized translators with expertise covering several technical areas.
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