Regulatory approvals: getting in the door is only the beginning

The challenges of getting your products approved in global markets are many, and only increasing. New technologies have made electronic submission formats possible, while harmonized dossier formats allow for simultaneous submissions around the world.

ForeignExchange Translations has helped drug and device companies get dossiers submitted quickly and with the confidence that translated documentation conveys the same meaning as the source documents. We also can translate your CMC documentation, clinical trial exhibits and create localization-friendly submission templates that will help you create dossiers more quickly and streamline the translation process. That means you get your dossier submitted sooner and your product to market faster.

Solutions for real world challenges

As a long-term solution, ForeignExchange proposed a new process for dossier development. Our client would write an English dossier, in the correct PMDA structure, with input on requirements from the Japanese affiliate. Then the dossier would be translated into Japanese and reviewed by the Japan office for language accuracy and adherence to appropriate PMDA standards. These reviews would be implemented into a final Japanese version that was then submitted to PMDA and archived at US headquarters.

“ForeignExchange has not only helped us to stay compliant and viable in what is one of our largest markets but has introduced the side benefit of improving our company teamwork across the world.” - large medical device company

Project types

Regulatory work includes:

Submission dossiers
CMC documentation
Clinical summaries
Exhibits
Labeling
Correspondence

Regulatory clients

Some of our regulatory clients include:

Abbott Laboratories
CIBA Vision
Hospira
Inverness
Johnson & Johnson
Wyeth