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