Streamline approvals and commercialization

Mitigate risk

You can’t afford to be casual about accuracy. We understand: we hold ourselves to the same standard.

Our quality management system is ISO 9001, ISO 13485 and ISO 17100 certified by TÜV SÜD America Inc. Within this system, we have developed a multilayered translation process that helps you:

  • minimize regulatory delays,
  • speed up your time to market, and
  • limit legal exposure related to translation errors.

Ensure regulatory compliance

We understand the importance of regulatory compliance, too. We’ve been helping companies adapt to regulatory changes around the world since 1983. We work with you to stay compliant with regulators at home and abroad on the documents that matter most:

  • instructions for use (IFU)
  • package inserts/prescribing information (PI/PIL)
  • user/operator manuals (UM/OM)
  • package labeling.

Build lasting partnerships

Why is our client turnover rate so low? Because we’re not just trying to race through your project to get to the next one. We see ourselves as trusted business partners, and we act accordingly.

We know that you invest a lot of time and energy in your suppliers. We do the same, and build translation teams for you that foster high quality and long-term consistency.