• Your 2nd Office in US

    Have you ever wonder how cool it would be to have a virtual presence of your establishment inside United States?

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  • FDA US Agent

    FDA requires foreign establishment to appoint a U.S. agent if they are engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States

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  • Quality & Regulatory

    Quality is a non-negotiable element of a successful business. Noncompliance to internal or external quality requirements could led up to unsatisfied customer, audit finding and unintended regulatory consequences.

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  • 21 CFR Part 11

    21 CFR Part 11 is a FDA requirement for electronics record and electronic signature. Not complying with 21 CFR Part 11 may result in FDA citations.

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In-Country Rep

Let us represent you in the United States of America

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FDA Part 11

Are you compliant to FDA 21 CFR Part 11?

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Services we offer

Beside our standard FDA related services, we also offer following services to our clients


Dedicated to your business needs

What makes us unique from everyone else is our dedicated service to you, our clients. We take your business very seriously and wholeheartedly   

CEO, Myusoffice