Medical, Pharmaceutical and Scientific Translations
We have more than forty years of specialisation in these sectors with the continuous and constant updating of our expert native-speaker translators, supported by the most advanced technologies.
We have created glossaries and carried out terminological research, allowing us to handle: pharmaceutical and medical/surgical documentation, medical analyses, communications to and from regulatory authorities, product information, summaries of product characteristics (SmPC), package leaflets (PL), labels, medical articles, press releases, veterinary documents, documentation for medical and electro-medical equipment in the diagnostic, surgical, orthopaedic and orthodontic fields, informed consent forms, clinical studies and records, protocols, experiments and everything necessary to obtain marketing authorisation overseas.
In the context of translating any type of medical or pharmaceutical regulatory document, we are aware of all binding regulations regarding the linguistic choices imposed by the competent authorities, including the Italian Medicines Agency (AIFA) and the European Medicines Agency (EMA).
This solid experience is also at the basis of the courses organised by CTI aimed at training translators and interpreters specialised in Medicine and Pharmacology. Our Master’s courses, one of a kind in Italy, are held by experts and respected professionals in the sector, who remain at our customers’ disposal for advice.
We take care of the German translation and certification of package leaflets for Trentino Alto Adige, also offering services for the creation of artwork and any related correspondence declarations.
Artwork, ready in PDF format for entry in the Farmaretedatabase, is created through the graphic layout of texts related to pharmaceutical products in full compliance with Unifarm layout and protection indications.
Correspondence declarations involve the re-reading and comparison of paginated artwork with the previously sworn texts in paper copy. The correspondence declaration is intended to certify the exact equivalence of the artwork to the sworn texts and is guaranteed by an electronic signature on the checked PDF document. After approval by the Ministry of Health, the validated electronic document can be directly supplied to pharmacies in Alto Adige, thus avoiding the dual language printing of the leaflets themselves and any related costs. We also issue correspondence declarations for artwork not prepared by us.
Obviously, package leaflets can be translated from and into any other language.
Readability Test – Italian Legislation – Law Decree 269/2003 Art. 48, P. 20
Our services include patient readability tests for package leaflets, which are compulsory for English texts.
The law states: “It is the owner’s responsibility to perform good quality translations that are not literal and that make sense according to the local culture”.In other words, if a patient does not properly understand a package leaflet since it is translated poorly and uses the product incorrectly with negative consequences, the owner can be held liable.
Our translators are specialised and professionally prepared to provide the best readability.
Specialised translations in chemistry for REACH
Our services include specialised translations in chemistry for REACH purposes: from cooperation contracts (SIEF Substance Information Exchange Forum and Consortiums) entrusted to technical, legal and administrative experts, to technical and scientific documentation assigned to specifically selected chemistry graduates.
Following the entry into force of Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning theRegistration, Evaluation, Authorization and Restriction of Chemicals (REACH),establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC,whose main aim is to improve awareness of the dangers and risks arising from existing chemicals (introduced to the market before September 1981) and new chemicals (introduced after September 1981) while protecting and strengthening the competitiveness and innovation of the EU chemicals industry, translation from and into English is requiredfor a wide range of technical documentation.
Since this is a Regulation and not a Directive, it does not require transposition or implementation and is immediately applicable in Member States, with staggered deadlines for the various chapters of the Regulation.