An Experienced REGULATORY Consultant You Can Count On

With over 25 years of experience and expertise in Medical device manufacturing including ELISA, CLIA, Rapid Tests, Serology, IFA and more, we provide full-service quality consulting and support to our clients with QMS documentation, QMS implementation, Training and Gap analysis and certification to be in compliance with FDA regulations, ISO and EC Directives requirements.

We will develop regulatory strategies tailored to our clients’ business and helping them achieving their goals reaching the global markets and expanding their business.

We assist with all types of facility registration with different regulatory agencies and prepare and submit application for all kind of required certificates effectively and quickly.

We regularly work with FDA, Notified Bodies, Competent Authorities, European Authorized Representatives and other global regulatory authorities

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Improve Your Credibility

In order to thrive, your business needs to build an established reputation. We can help you gain the trust of your market through the following:

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Through our ramp-up process, we can empower your team and equip them with the tools they need to succeed. Consult with us today about how we can support your company’s growth, limit your turnover, and put you on a solid track to success and profit.