Submissions to Regulatory Authorities

Accuracy and compliance are our top priorities in translation. We strictly follow the regulatory review regulations and establish strict quality control procedures to ensure that your product is legally compliant and can be quickly launched.

Our services

The accuracy and compliance of medical information have a direct effect on patient health outcomes. Therefore, an accurate grasp of local regulations and relevant language is crucial. Our rich professional knowledge and extensive experience make us experts in these fields:
  • Instructions

    Medicine labels

  • Common Technical Documentation (CTD)

    Correspondence with regulators

  • Packaging

    Patient prescription information

  • Labeling/SmPCS

    Patient Information Lists (PIL)

How we can help you succeed

We have helped many pharmaceutical groups and international pharmaceutical companies successfully complete regulatory processes. Our experienced medical translators and proofreaders and team of industry experts complete all translation work. They are well versed in the regulatory laws and regulations of Europe, Asia and the United States, and with the help of a sound regulatory process, they help ensure the accuracy and compliance of all translations. They can also provide additional digital content promotion solutions to help you bring a more meaningful experience to your customers.

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