We specialize in FDA and CE regulatory compliance, as well as commodity sales and trading.

US FDA Registration
Register your establishment and medical device to appear on the FDA website.
USA FDA Approval
FDA 510(k) Clearance

We help manufacturers apply for and receive US FDA approval for their products. Our FDA Approval Services include:

  • Evaluate your medical device description and intended use to determine your medical device’s product classification
  • Identify FDA Recognized Consensus Standards that apply to your product (such as Electrical Safety and Biocompatibility), and any product specific FDA Guidance Documents
  • Recommend the optimum predicate device to compare your device’s performance when developing the 510(K)
  • Write and assemble your submission documents using your technical documentation
  • Provide consulting services and project management services by coordinating with third-party testing labs for Consensus Standards testing
  • After you review and approve the draft of your submission document, we will submit it in your behalf to the FDA

 

COVID-19

We help manufacturers of PPE and medical devices quickly apply for and receive the fast-track US FDA approval under the current FDA Emergency Use Authorization.

EU CE Marking
We help manufacturers apply for and receive CE certification for their products. Our CE Marking Services include:
  • Evaluate your medical device description and intended use to determine your medical device’s product classification
  • Identify EU Recognized Consensus Standards that apply to your product (such as Electrical Safety and Biocompatibility), and any product specific guidance documents
  • Write and assemble your submission documents using your technical documentation
  • Provide consulting services and project management services by coordinating with third-party testing labs for Consensus Standards testing
  • After you review and approve the draft of your submission document, we will submit it in your behalf
  • We can also help you find a Notified Body for CE Mark certification
DUNS Number

The FDA requires all foreign businesses to have a DUNS number in order to register your establishment or submit any documentation to the FDA. We can obtain a DUNS number for your business.

Sales
Marketing

We work to expand your global market reach. Our services include digital marketing, product placements and promotions, and local marketing and sales teams.

Distribution and Wholesale

Let us handle all of your distribution and wholesale needs, so that you can focus on what you do best - your business.

Import/Export
Import

We have a network of trusted suppliers who are able to fulfill your production needs.

Export

Our brokers work to locate business opportunities and facilitate transactions to increase your sales.