We help you navigate successfully the linguistic review process
In recent years, product development within the pharmaceutical industry has quickly picked up pace. Together with globalisation, this has led to a growing need for professional pharmaceutical translations.
If you are looking for specialist pharmaceutical translation services, then we are here to offer accurate pharmaceutical translations you can rely on.
Guided by our commitment to quality, we work with experienced subject matter experts to deliver accurate translations that undergo thorough quality control measures. As an ISO 17100:2015 certified language service provider, we do everything possible to ensure your translation meets the highest standards.
With people’s lives and health depending on pharmaceutical documents, the medical industry imposes the strictest regulations. Product labels must include certain types of information in the official languages of the country where the products are marketed. As such, it is important that you find a specialist translator who understands the regulations of your target market.
Experienced pharmaceutical translations from an agency you can trust
At Intertranslations, we have over 20 years of experience in dealing with regulatory agencies, health ministries, and drug control institutions. This experience allows us to understand even the most complex regulations, adding extra value to our linguistic skills.
During this time, we have also built up a wide network of specialist translators. By choosing an experienced linguist with a proven track record for producing high-quality work, we can deliver accurate translations within your deadlines.
Our expertise in pharmaceutical translations has been built on these three pillars:
1. Subject Matter Experts – Human Resources
We follow a strict selection process for choosing pharmaceutical translators based on the following criteria:
- Qualified university graduates and native speakers in your target language.
- Minimum of 3 years’ experience in the pharmaceutical or medical field.
- Expert language leaders hold an MD or PhD degree.
We like to make sure our clients are getting the best value. As well as our basic criteria, we also go above and beyond to ensure the quality of your translation.
- We know that even the best translator cannot excel in all fields. Once we narrow down our selection, we further classify our translators into multiple categories.
- Our translators specialise in specific document types. They understand the subtle differences between a summary of product characteristics and patient information leaflets, as well as product information, marketing materials and journal articles.
- For manufacturing documents, we select translators with expertise in the Pharmacopoeia of your target market.
- We work with specialist linguists who have in-depth knowledge of the ATC code and Pharmacotherapeutic groups.
- Our linguists have experience with regulatory authorities, health ministries and control institutions, demonstrating a detailed understanding of regulatory knowledge.
When we receive a document from you, we will first analyse the text. Based on its specific characteristics and target audience, we will assign your project to the best team for your translation.
For example, if you are looking to translate package leaflets, then we will select medical translators with experience in translating this type of document. They will have previously shown that they can translate information to suit the needs of a general audience, while also staying faithful to the source text.
We are committed to growing and developing a team of experts who can deliver translations of the highest quality.
- Continuous training
Regulations are constantly changing, and it is important that translators keep up to date to ensure the accuracy of your translations. We organise webinars to inform our translators about any changes regarding regulations, from changes in product information templates and labelling guidelines to terminology.
These changes are also updated in our online database, ready for our translators to use during the translation process. This improves efficiency and productivity, speeding up the translation process while ensuring a high quality.
- Expert project managers and translation and localisation consultants
At Intertranslations, we invest in our project managers and account managers. We deliver regular training in linguistic review procedures and regulatory affairs, as well as medical and Good Manufacturing Process terminology. This knowledge allows them to communicate freely between clients and translators, while also ensuring that the quality and accuracy meets your strict requirements.
- Continuous evaluation
Our team is evaluated and tested on a regular basis. For each submission, we keep track of the feedback our client receives from the regulatory authorities. We discuss the proposed changes with each translator individually, and we constantly work together to improve the translation. We also conduct readability tests with specialist companies to ensure that our translators comply with the relevant guidelines.
- Comprehensive services
Offering a full range of DTP services, we can complete your project in-house. We help our clients create mock-ups of the artwork, also creating PDF versions of the product information according to EMA guidelines. This way, we can streamline the entire process and get you quality results faster.
2. Quality control
Our commitment to quality runs through every stage of the translation process. ISO 17100:2015 certified, we follow translation industry standards for core processes and resources to ensure the quality of your translations.
We have developed a strict quality control process when completing your translations:
- The translator proofreads the translation.
- A second translator, known as a ‘reviser’, examines the translation against the original document to check for accuracy.
- Members of the translation team will discuss any differences between the original and the translation, making necessary changes and reaching a final agreement.
- The team carries out a final proofread to ensure the highest standards in the language used.
We also take a number of extra steps to ensure your translation complies with the strictest quality standards:
- Before we start the translation, we analyse the source text and identify any areas containing figurative language or ambiguity. Any confusion in the source text could lead to a confusing target text, and so we work with our clients to improve the original document. This gives your project the strongest chance of success.
- During each step of the translation, we run an automatic quality assurance (QA) check to ensure the quality of your translation. This includes checking numbers and symbols, as these carry significant medical information. Even the smallest error could have significant consequences, and the QA tools we use will signal any deviations from the original.
- We carry out additional editing and proofreading for specific sections which are especially complex. For example, our team will run additional quality assurance steps for sections 4.2 and 4.8 within a Summary of Product Characteristics document.
3. Translation Management System
We use a range of tools that allow us to deliver quality translations with a fast turnaround. This includes:
- Computer-Assisted Translation (CAT) tools
We use CAT tools throughout the translation process. This ensures a consistent use of terminology throughout your documents, while also improving the productivity of our translators.
We also take several extra steps to make our processes even faster while giving you peace of mind about the quality. This includes:
- Individual client glossaries
Our clients will receive an individual glossary, detailing the terms preferred by our client or the regulatory authorities. These glossaries are then uploaded into our CAT tools ready to use. This ensures consistency and accuracy throughout the translation.
- Client translation memories
Once our client approves a translation, we add the data to their individual translation memory. We are then able to use this content for all future projects, drawing on previously translated text to ensure consistency with future texts. With discounts on repeated text, this also reduces translation costs over time.
- Global glossaries
Our CAT tools incorporate glossaries from Good Manufacturing Process, European Pharmacopoeia and United States Pharmacopeia, European Medicines Agency and MedDRA. Each translator has direct access to these glossaries during their projects, making sure they use approved terminology.
- Project-specific translation memories
We create translation memories based on the specifics of each project. For example, the Dutch template for mutual recognition procedures is different to the one for centralised procedures. The project manager selects the specific translation memory matching your project, ensuring a correct match.
- Strict time management
Our system monitors the progress of the translators in real time to avoid any delays in completing your translations. The project manager is instantly notified if there is even a slight delay, allowing them to quickly intervene and get the project back on track. We know that timelines for submissions are strict, but with Intertranslations, you can be sure your deadline will never be missed.
- Clear records
Since all the data is stored in our system, you will be able to demonstrate compliance to the regulatory authorities. Our records will show that your translation was completed according to strict quality standards, following all the necessary steps to ensure its accuracy.
- Automated workflow
Once one step of the project is complete, the document is automatically forwarded on for the next person to begin their work. This automated workflow saves time and ensures optimum efficiency.
- Smooth client approval
Our clients can review their translations directly in our system to help streamline the process. This means that your approved changes will be automatically added, and do not need to be uploaded afterwards by another team.
- Tight security controls
Using a secure internal system, we never use email to send files outside of our company. This ensures total confidentiality, protecting the privacy of our clients. We can also put restrictions in place, limiting what translators may access and preventing them from downloading your confidential files.
Nothing is stored outside our system, and it is these high security measures that allowed us to become ISO 27001:2013 certified.
Top 5 benefits of working with Intertranslations
- Our strict management system will leave you feeling confident and secure.
- Quality assurance by combining QA tools with qualified subject-matter experts.
- Translation memories to reuse content, delivering quality assurance, consistency and 23.4% savings over time.
- Close monitoring of the translation’s progress, ensuring over 98% of projects are delivered on time.
- Large online database of templates, resources, references, medical glossaries and guidelines to ensure full compliance with regulations.
What texts do we translate?
- Product information
- Packaging text
- Labelling text
- Adverse event data and documentation
- Clinical trial documents
- Standard operating procedures
- Training documents
- Batch records
- Certificates of Analysis
- GMP documentation
- Pharmacovigilance (PV) material
Ready to get started on your pharmaceutical translation project? Request your free quote or get in touch to talk with one of our pharmaceutical experts today.
The following are types of documents that we frequently translate:
- Installation, operation, maintenance, and user manuals
- Material Safety Data Sheets (MSDS)
- Standard Operating Procedures (SOPs)
- Engineering texts
- Manuals for machine tools and other machines
- Tender documents (RFPs, RFIs, RFQs, etc.)
- Description and technical data sheets
- User guides
- Technical instructions
- Instruction books
If you want to know how we can help you take advantage of our expertise in technical document translations just click on the link below: