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Regulatory Focus™ > News Articles > Quality & Compliance: Best Practices for Japan Regulatory Submissions by US Companies

Quality & Compliance: Best Practices for Japan Regulatory Submissions by US Companies

Posted 01 November 2009

Many companies that do business in Japan rely on their Japanese affiliates to handle the creation of regulatory documentation due to language and cultural considerations and the complexities of Japanese regulations. A problem with this approach is that often the US-based companies don't know exactly what was submitted to the government, and that can have serious implications if there are questions or field issues with the product later.

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