The pharmaceutical industry is considered to be one of the most competitive in the world. Pharmaceutical companies must navigate comprehensive patenting regulations and manage intense competition from generic drug providers in order to get their drugs to market. Time is of the essence, so speedy translation is crucial.
In such a heavily regulated industry, there are significant variations between the rules that govern different global pharmaceutical markets. Everything from pre-clinical documentation to pharmacological studies to product labelling must be translated with the utmost care. Mistakes can have costly legal ramifications and can exclude companies from entire markets, so an experienced provider of pharmaceutical translation services, one who understands these regulations, is essential.
Our services in this field
For safe and effective usage, translations must be easily understood not only by regulators and medical providers, but also by end-users. This requires the translator to take into account cultural as well as linguistic differences. Failure to do so can have potentially life-threatening consequences for patients, so there is no room for error or misinterpretation. Medtrans has a large team of certified pharmaceutical translation experts and editors with extensive professional experience in the pharmaceutical industry.
Documents we commonly translate:
- Registration dossiers
- Regulatory documentation
- Patents and patent applications
- Summary of product characteristics
- Pharmacological studies
- Clinical study protocols
- Investigator brochures
- Patient information leaflets (PIL)
- Instructions for use
- Packaging and inserts
- Product licences
- Master batch records
- Manufacturing information
- Sales and marketing materials
In addition to our translation services, we offer proofreading, back-translations, editing/laying out, transcription and data entry. Our capable team is always happy to take on new challenges, and our capacity usually always allows us to accommodate new and challenging projects. Our aim is to be the vest pharmaceutical translation provider for each of our clients.
All of our translators are accredited by the National Accreditation Authority for Translators and Interpreters (NAATI) as a minimum standard, and we can also provide US- and EU-accredited translators as needed. We work in over 130 different languages and dialects, covering all major pharmaceutical markets. Translators work in their native language, and are conversant with all related pharmacological terminology in both the origin and the source language.
After it has been translated and then proofread by a certified team member, the work undergoes methodical inspection to assure complete cultural, linguistic and technical accuracy as well as compliance with all relevant regulations. There is also the option of having your documents further proofread by up to two native-speaking, independent editors with expertise in the pharmaceutical field. You can also choose typesetting, which will give your document a professional, ready-to-publish finish.
We do understand how sensitive pharmaceutical documents are, and have measures in place to ensure all relevant compliance. All our pharmaceutical translators are subject to binding non-disclosure agreements, and we can also sign extra confidentiality agreements if requested.
Contact us now for a free quote on your pharmaceutical translation project.
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Team of Translation Project Managers
Medtrans is a provider of medical translation solutions
in Australia with 10 years of translation experience.