Raphas, a Leading Microneedle Patch Manufacturer in South Korea, Achieves Outstanding FDA cGMP Inspection Results Through Collaboration with Provision Consulting Group

Date: 11/3/2023

Raphas, a leading innovator in microneedle patch technology, develops and applies its products across a wide range of fields, from cosmetics to pharmaceuticals. As part of its strategic entry into the U.S. market, Raphas was introduced to Provision Consulting Group ("PCG" by POSCO, with whom PCG has an established MOU. Together, they prepared for the critical FDA cGMP inspection process.

The FDA cGMP inspection is a rigorous evaluation to determine whether drug-delivery microneedle patches meet the stringent Good Manufacturing Practice standards enforced by the U.S. Food and Drug Administration (FDA). Successfully passing this inspection is a significant milestone for companies seeking to export pharmaceutical products to the U.S. market.

PCG supported Raphas throughout the entire preparation and inspection process. Beginning with a comprehensive mock inspection, PCG accurately assessed Raphas' cGMP compliance, identified key areas for improvement, and provided targeted, timely consulting.

During the actual FDA inspection, PCG was present on-site, offering real-time regulatory consulting, interpretation services, and strategic communication support as Raphas' regulatory spokesperson.

Throughout the FDA’s demanding and meticulous questioning, PCG's expertise and strategic guidance helped facilitate favorable discussions and outcomes for Raphas. As a result, Raphas successfully passed the FDA inspection, paving the way for the export of its microneedle pharmaceutical patches to North America.

- Provision Consulting Group’s Co-CEO, Sung Kwon, providing consulting services during the final preparation for the FDA factory inspection audit in March 2023.

- Meeting between Provision Consulting Group and Raphas executive management regarding the FDA inspection process.

The CEO of Raphas stated, “Successfully passing the FDA inspection has laid a strong foundation for us to begin exporting our microneedle patch medicines to the North American market. Building on this achievement, we anticipate expanding our full-scale sales efforts in both the U.S. and South Korea.” https://www.pharmnews.com/news/articleView.html?idxno=227906

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