Regulatory Compliance Translation Services

To remain competitive in today’s medical industry, companies must cater to a growing number of major international markets. Each market is tightly controlled by its own regulatory and governing bodies, presenting a unique set of challenges to medical, pharmaceutical and biotech organisations. Regulations can vary significantly from market to market. They are incredibly complex and require the strictest compliance, as failure to meet the prescribed standards can incur costly legal penalties and prevent companies from accessing major markets entirely. There is simply no room for error.

Our services in this field

With such high stakes, using a standard translation service is a risk that no medical organisation can afford to take. Medical compliance translation is a highly specialised discipline requiring years of experience in international regulatory compliance, and a solid understanding of the nuances between markets. Medtrans has a large team of certified translators and editors with extensive professional experience of international medical regulatory compliance. We are deeply committed to being the best regulatory compliance translation service provider.

Documents we commonly translate:

  • Approval dossiers
  • Summary of product characteristics (SmPC)
  • Packaging and inserts
  • Labelling
  • Validation protocols
  • Patient information leaflets (PIL)
  • Instructions for use
  • Clinical trial documentation
  • Informed consent forms (ICF)
  • Case report forms (CRF)
  • Risk assessments
  • Biocompatibility reports
  • Manufacturing procedures

Additional services

In addition to our regulatory compliance translation services, we offer proofreading, back-translations, editing/laying out, transcription and data entry. Our capable team is always keen to take on new challenges, and our capacities unsure that we can usually accommodate new and challenging projects comfortably. 

Competency

All of our regulatory compliance 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 regulatory compliance areas. Translators work in their native language and are conversant in all related terminology in both the origin and the source language.

Quality management

Once translated and proofread by a certified team member, work is methodically inspected to assure it is completely accurate linguistically, technically and culturally, and complies with all relevant regulations. You can then choose to have your documents further proofread by up to two independent, native-speaking editors with expertise in the regulatory compliance field. There is also the option of typesetting to ensure your document has a professional, ready-to-publish finish.

Confidentiality

We are well aware of the sensitive nature of regulatory compliance documents, and have measures in place to ensure compliance with all relevant standards. All our regulatory compliance translators are subject to binding non-disclosure agreements, and if requested, we will also sign additional confidentiality agreements.

Contact us now for a free quote on your regulatory compliance translation project.

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Medtrans is a provider of medical translation solutions
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