Medical translation for medicinal product marketing authorisations and all internationalisation projects

Localisation is an absolute prerequisite for successful global product marketing. Therefore the bulk of any internationalisation process involves translation and localisation tasks, and they serve as the basis for any globally successful product.

Consequently, these tasks are considered the highest priority in all orangeglobal projects and are efficiently integrated into the workflow.

The orangeglobal group is able to utilise state-of-the-art methods and processes thanks to the cross-departmental expertise of its organisation, in which marketing authorisation experts working together with linguists professionally analyse and organise medical language processes.

Translation of medicinal products
orangeglobal’s approach

Quality doesn’t happen by chance - only a well organised translation is also a professional translation.

The orangeglobal group has made this approach its top priority when it comes to organising and carrying out product-specific language processes.

Quality can only be assured by a process optimally adapted to customer and document requirements that far exceeds conventional standards, using all necessary subject experts and systems and with standardised implementation, including SOPs. The orangeglobal group’s business model is organised around the idea that the different departments (Regulatory Affairs, Pharmacovigilance, Studies and Marketing) with their scientific experts work together in an interdisciplinary manner with the translation and language department.

Obtaining translations of the highest quality eliminates protracted correction loops on both sides, which traditionally involve significant costs and can complicate the submission process considerably. At the same time, the systems used as part of this process guarantee not only improved quality, but also permanent cost reductions for every project or product.

Harmonisation and optimisation starts with conducting a potential analysis of your current situation and will be defined and monitored in a joint goal-setting session involving precisely defining milestones and results.


Your specialist for translations for medicinal product marketing authorisations

The orangeglobal group uses its subsidiary mpü translations to do medical translations and to carry out all corresponding language processes. mpü is the specialist for technical translations for medicinal products. mpü translations naturally offers all of the services typically provided by a cutting-edge language service provider specialising in the healthcare industry while also maintaining the highest safety standards.

In addition to the latest language technologies (CAT tools, terminology databases), we also use testing and validation tools developed in-house for specific quality checks appropriate for the document type. We develop, in consultation with our experts in the competence centres of

Regulatory Affairs | Labelling | Studies | Marketing | IT | Language Management | Multilingual DTP Service 

your product- and company-specific processes.

We are your partner for subtasks, single translation or process stages or your entire project and process flow.

 

Medical translations - Pharmaceutical translations

We assist you with all your language and translation requirements in

• Human medicine
• Dentistry
• Veterinary medicine
• Pharmacy
• Chemistry
• Biotechnology
• Biology, etc.

and guide your documentation throughout the whole product life cycle.

Translation for clinical trials

As an ISO 9001:2008 certified provider, we will help you with translation and localisation processes for

all documents before, during and after a study.

Our translation management for clinical studies is focused on on-time, error-free completion of your projects in accordance with GCP guidelines, adapted to your study plan and in line with regulatory requirements:

- Preclinical studies
- Phase I–IV clinical studies
- Post-marketing surveillance studies
- Non-interventional studies (NIS)

Translation and linguistic validation of patient reported outcomes (PRO)

In accordance with the ISPOR, FDA and EMA guidelines, we have developed a quality-assurance process that satisfies all of the customer’s requirements and those associated with the specific document type.

It comprises all of the requested quality assurance steps, such as review, back translation, review of the back translation, interviews etc., to meet the high quality standards for sensitive documents for multinational studies.

Translations for medicinal product marketing authorisations

Our translation and language management system for regulatory affairs focuses on the on-time, error-free completion of your projects, including compliance with the relevant regulatory or procedural directives.

Dossier translations

Translation and formatting of all modules (1–5)

- Preparing the documents in electronically editable Word formats
- Technical translation and review in the desired language
- Creating the dossier in CTD / eCTD format

Labelling translation – CP, DCP, MRP, NP
Translation of variations – Type Ia/Ib, type II

SmPC, PL and label translations for all regulatory submission procedures:
- CP
- DCP and MRP
- National procedures
- Variations type Ia/Ib, type II
- Line extensions/renewals
- Linguistic review

- Tried and tested process for labelling and variation translations
- Prompt delivery within the defined time frames
- Take into account all regulatory requirements such as EMA QRD, EDQM Standard Terms, lay terms, etc.
- Various service packages depending on the regulatory requirements or processes
- Consistent quality and efficiency by using the latest software, labelling terminology databases, quality assurance tools, testing and validation tools

Because the orangeglobal group provides a comprehensive, interdisciplinary range of services, it is able to offer a process specifically for labelling and variation translations of SmPC / PL / labels that meets all time management and safety requirements, and that ensures acceptance by the authorities.

Translations for marketing purposes

Perfect marketing communication on a global scale - transcreation instead of just translation

Whether in print or online – whether for translation, transcreation or localisation – our processes are specifically geared to the requirements of the medicinal product sector, always in combination with the necessary creativity and focusing on the relevant local target group so that sensitive messages are transferred into the other language exactly as intended:

• Transcreation: Creative, content-based, marketing-oriented localisation of claims, advertising messages, etc.
- Creative and medical writing, also reviews
- Visual localisation of layouts, artwork, etc.
- Multilingual desktop publishing

and much more.