"Just in time" registration documents

Translation

Since in the submission of registration documents the 'registrability', i.e. the quality of the documents submitted, is of vital importance and the objective, i.e. "the approval", can be substantially delayed by unclear documents, pertaining to all registration processes regardless of the authorities, our scientific staff and linguistic experts are constantly trained in these requirements and kept abreast of changes.

The submission of registration documents - often a vital milestone in the development of a new drug - mpue specialists are familiar with all the registration dossiers of the 5 CTD/eCTD modules for the ICH regions of Europe, USA and Japan.

Whether EMEA or Swiss-Medic templates, EDQM standard terms, MedDRA, BfArM, FDA, MHLW, MHRA etc., mpue and its scientific linguistic experts are always up to date with the latest specifications, legal requirements and global changes. In-house templates can also be stored at mpue and used as required.

mpue - flexible and fast

National, centralised and decentralised (MR) procedures - mpue specialists are totally at home and geared to flexible and rapid handling of these projects.

Whether 150 pages in 3 days, 500 pages in 1 week, SPC + PIL in 20 languages over the weekend - mpue has the solution.

Preparation of SPCs und PILs

When short lead times have to be met in the registration process and SPCs, PILs and labels still remain to be compiled in one or more languages and have to be available simultaneously - mpue also supports you in your editing process.

Based on your instructions, we prepare from your data material and your raw data (tables, graphs and statistics) a model document geared to the state of knowledge and the information needs of the target audience.

We formulate and structure your SPCs, PILs and labels in all EU languages in accordance with the standardised EU requirements of BfArM, EMEA, MedDRA und EDQM standard terms.

The scientific linguistic experts and communication professionals from mpue - doctors, pharmacists and medical writers - compile a master document in the base language required. All other languages are based on this master document.

Case studies

Harmonisation of SPCs & PILs

Whether you are engaged specifically in a national or centralised registration or a mutual recognition procedure (MRP), we harmonises or adapts your SPCs or PILs in accordance with your specific registration process and the official requirements.

Processes

At whatever stage of the registration process you are, mpue assumes responsibility for all the work processes pending for the harmonisation of SPCs and PILs.

We structure your existing SPC + PIL according to the “QRD Templates” in order to meet official requirements and also ensure patient friendliness. In this we can draw on our experience and knowledge acquired with the Readability User Tests.

Different Member States - one SPC

Hand us the SPCs for all your 'Member States', we will combine country-specific information in one 'Core SPC' and we will compile your localised PILs from this.

Readability User Testing for PILs

mpue has adapted early to the new legal requirements imposed at EU level on the pharmaceutical industry und developed a test procedure in line with the directive.

In all registration processes it must be shown that the patient information leaflets (PILs) for medicines have been tested for legibility, i.e. for clarity and comprehensibility for the potential user of the medicine. Readability User Testing is the procedure by which PILs are tested and reformulated to ensure they meet these requirements. This has been law since October, 30 2005 and is a constituent part of registration: for first registrations and at present for all generics.

We carry out this Readability User Test in German in our headquarters in Germany and in English in our UK office, according to the requirements of your registration processes.

	Medicine and Pharmacy Translation Localisation mp4 Translation Variants Translation Technology Technology in the Translation Process Translation Memory Technology DTP with Translation Memory Languages Specialist areas Licences: Translation\|Drafting\|Harmonisation Patents Biotechnology Translation Localisation mp4 Translation Variants Translation Technology Technology in the Translation Process Translation Memory Technology DTP with Translation Memory Languages Specialist areas Patents Research Projects Medical Technology and In-Vitro Diagnostics Translation Localisation Translation Technology Technology in the Translation Process Translation Memory Technology DTP with Translation Memory Languages Specialist areas Desktop Publishing Multilingual Desktop Publishing Foreign Language Typesetting, Fonts and More Interpreting Cross Culture Asia Integration	"Just in time" registration documents Translation Since in the submission of registration documents the 'registrability', i.e. the quality of the documents submitted, is of vital importance and the objective, i.e. "the approval", can be substantially delayed by unclear documents, pertaining to all registration processes regardless of the authorities, our scientific staff and linguistic experts are constantly trained in these requirements and kept abreast of changes. The submission of registration documents - often a vital milestone in the development of a new drug - mpue specialists are familiar with all the registration dossiers of the 5 CTD/eCTD modules for the ICH regions of Europe, USA and Japan. Whether EMEA or Swiss-Medic templates, EDQM standard terms, MedDRA, BfArM, FDA, MHLW, MHRA etc., mpue and its scientific linguistic experts are always up to date with the latest specifications, legal requirements and global changes. In-house templates can also be stored at mpue and used as required. mpue - flexible and fast National, centralised and decentralised (MR) procedures - mpue specialists are totally at home and geared to flexible and rapid handling of these projects. Whether 150 pages in 3 days, 500 pages in 1 week, SPC + PIL in 20 languages over the weekend - mpue has the solution. Preparation of SPCs und PILs When short lead times have to be met in the registration process and SPCs, PILs and labels still remain to be compiled in one or more languages and have to be available simultaneously - mpue also supports you in your editing process. Based on your instructions, we prepare from your data material and your raw data (tables, graphs and statistics) a model document geared to the state of knowledge and the information needs of the target audience. We formulate and structure your SPCs, PILs and labels in all EU languages in accordance with the standardised EU requirements of BfArM, EMEA, MedDRA und EDQM standard terms. The scientific linguistic experts and communication professionals from mpue - doctors, pharmacists and medical writers - compile a master document in the base language required. All other languages are based on this master document. Case studies Harmonisation of SPCs & PILs Whether you are engaged specifically in a national or centralised registration or a mutual recognition procedure (MRP), we harmonises or adapts your SPCs or PILs in accordance with your specific registration process and the official requirements. Processes At whatever stage of the registration process you are, mpue assumes responsibility for all the work processes pending for the harmonisation of SPCs and PILs. We structure your existing SPC + PIL according to the “QRD Templates” in order to meet official requirements and also ensure patient friendliness. In this we can draw on our experience and knowledge acquired with the Readability User Tests. Different Member States - one SPC Hand us the SPCs for all your 'Member States', we will combine country-specific information in one 'Core SPC' and we will compile your localised PILs from this. Readability User Testing for PILs mpue has adapted early to the new legal requirements imposed at EU level on the pharmaceutical industry und developed a test procedure in line with the directive. In all registration processes it must be shown that the patient information leaflets (PILs) for medicines have been tested for legibility, i.e. for clarity and comprehensibility for the potential user of the medicine. Readability User Testing is the procedure by which PILs are tested and reformulated to ensure they meet these requirements. This has been law since October, 30 2005 and is a constituent part of registration: for first registrations and at present for all generics. We carry out this Readability User Test in German in our headquarters in Germany and in English in our UK office, according to the requirements of your registration processes.