Get Your Device to Market Worldwide

Clinical and Preclinical

You’re dealing with patients, investigators, clinicians, and regulators…and everyone has their own needs.  We translate both from and into English so you can keep headquarters briefed, your notified body happy and your ethics committee fully satisfied.

To ensure timely translations of clinical content, we also work directly with:

Regulatory

Your regulators, at home and abroad, have a long list of documents they want in their local language, from clinical findings to labeling and even localized software.  We translate documents for:

  • FDA
  • EMA
  • European NCAs and NBs
  • PMDA
  • SFDA
  • other regulatory bodies in Asia, Latin America, or the Middle East.

You cross every “t” and dot every “i” before submitting regulatory documents.  So we do the same with a multilayered translation process that has been certified to international standards for quality.

Post-market

Marketing authorization in hand, you’re ready to take your device global.  As you launch your website, equip your sales team with marketing materials, or prepare your stakeholders with worldwide training content, our translations will amplify your impact.

And because we know that you’re always monitoring the safety of your device, our translations support your postmarket safety activities:

  • surveillance
  • follow-up studies
  • field safety actions
  • recalls.