Translation Minefield In The Pharmaceutical Industry
Operating internationally, pharmaceutical companies are required to provide translated materials to countries across the globe. The bigger scale comes with higher risks. If the information in your regulatory submissions, patient information leaflets, or packaging labels is not translated with absolute accuracy, it can lead to irreversible consequences.
The minefield of translation in the pharmaceutical industry
The pharmaceutical translation is functioning in an extremely niche services field. Different than other industry, a translation fault in the pharmaceutical industry does not only lead to a downgraded reputation or financial loss. Any mistake in the pharmaceutical industry results in irrevocable results such as injuries or deaths. Furthermore, while the direct cost of translation is insignificant, translation can cast a massive shadow—for better and for worse—on several critical factors. These factors are the total cost of the trials, the time to market, the possibility of lawsuits or rejection by regulators and the safety and efficacy of the marketed product.
In particular, regulators likely disapprove and delay their approval to pharmaceutical applications if the translations on required materials are inadequate. As a consequence, the business schedule is delayed accordingly and causes loss of competitiveness. More importantly, the research and trials processes of this industry are performed on a global scale. This process is no longer performed in one country. Inadequate translation can disrupt communication between research sites. This “lost” connection can flag the sponsor that the compound tested is a “blockbuster” or a “poison”.
Navigate through translation minefield in the pharmaceutical industry
Accurate translation is required from the beginning of the product innovation process to the marketing and the post-consumption process. Therefore, the translation team of your company needs to be equipped with up-to-date technical knowledge and accurate understanding of medical terms. Multiple levels of quality control and a full understanding of stringent regulatory laws is another necessity, especially the regulations of new drug development and marketing in the United States, the European Union, Australia, and Japan.
Elionetwork provides translation services that cover high accuracy level in every translation job. We have professional pharmaceutical translation services with highly experienced experts in pharmaceutical terms and concepts. We translate pharmaceutical and medical documents from over 55 languages, including major languages of Western and Eastern Europe, Asia, America, and Africa. Our translation services are qualified with ISO 17001:2015 Quality Assurance policy. This proves that our process is equipped with multiple levels of quality control and a comprehensive understanding of the legal system. Let us help you with your translation needs.
You may want to contact us for translation documents such as:
- Adverse Event Source Documents
- Case Report Forms (CRFs)
- Data Sheets
- Development Safety Update Reports (DSURs)
- Drug Registration Documentation
- Endpoint Adjudication Documents
- Informed Consent Forms
- Insert Leaflets
- Instructions for Use (IFUs)
- Marketing Collateral
- Master Batch Records
- Package Inserts and Labels
- Patient Diaries
- Patient Recruitment Materials
- Patient Reported Outcome Measures (PROMs)
- Patient Source Documents, Admission and Discharge, Labs
- Pharmacological Studies
- Product Labels
- QoL Scales
- Regulatory Documents
- Scientific Papers
- Study Protocols
- Suspected Unexpected Serious Adverse Reactions (SUSARs)
- Toxicology Reports