R company develops microneedle products with innovative technology and applies them to various fields and is actively engaged in various fields from cosmetics to medical fields. Company R was introduced by POSCO to Provision Consulting Group, which signed an MOU with POSCO and prepared for this FDA cGMP (Quality Management Standard) inspection prior to entering the US market.
This FDA inspection is an important procedure to review whether microneedle drug patches comply with the U.S. Food and Drug Administration's good drug cGMP, and is known to be a rigorous and demanding process. From mock inspection consulting to actual FDA inspections, Provision helped Rapace successfully complete the FDA inspection.
During the mock inspection, we diagnosed Raphas' cGMP compliance, accurately identified necessary improvements, and provided prompt consulting. During the FDA inspection period, we were always on site. We provided consulting by providing real-time interpretation, advice, and acting as a regulatory spokesperson.
In particular, during the FDA examiner's strict and demanding questioning process that continued during the inspection period, Provision's expertise and capabilities led to discussions and discussions favorable to Company R, and as a result, , Company R successfully passed the FDA's inspection, making it possible to export microneedle medicine patches to the North American market.
- Provision's co-representative Seong-gyeol Kwon is providing consulting services in preparation for an FDA factory inspection audit in the last week of March 2023
- Meeting with Company R management regarding FDA inspection
An official from Company R said, “With the passing of this inspection, the foundation for exporting microneedle patch medicines to the North American market has been laid.” “Based on this, we expect to realize and expand full-scale sales in the U.S. and Korea.” Through this cooperation, Company R will strengthen its position in the U.S. market and continue to expand its performance in the microneedle pharmaceutical patch field. It is expected that this will accelerate our expansion into the global market.
Provision work professionally while meeting clients' needs.
We will streamline the regulatory processes so that our clients can utilize their time
and money most efficiently.
Experience the best FDA approval directions and solutions!
If you have questions about FDA regulation of Medical devices,
OTC Drugs, Cosmetic or importing of medical devices to the United States,
Please CONTACT US,