Technology
Quality Excellence
Raphas Quality Excellence
Starting with Korea's first functional cosmetics certification for microneedles,
we apply uncompromising, rigorous standards to our quality.
We have acquired three major ISO and GMP international certifications, and proudly became the world's first to pass the US FDA's OTC drug GMP inspection, proving our world-class manufacturing management capabilities.
We conduct meticulous verification processes across all stages, from raw material receiving to final product shipment. We consistently maintain excellent ratings in rigorous quality evaluations conducted by domestic and international government agencies and global partners.
By applying the exact same quality control system to all product lines—from cosmetics to highly complex pharmaceuticals—we deliver absolute confidence to our partners and safe, reliable value to end consumers.
Certification Status
ISO 22716 is the international standard for Good Manufacturing Practices (GMP) for cosmetics, providing detailed guidelines to ensure product safety, hygiene, and quality.
Through our ISO 22716 certification, we maintain strict management systems across the entire process—from raw material receipt to production, packaging, and shipment—delivering safe and reliable products that meet global standards.
ISO 13485 is an international standard for quality management systems for medical devices and related services, emphasizing medical-grade safety and compliance with regulatory requirements.
Based on this certification, we manufacture high-quality functional products, including microneedle patches, providing global clients with stable, regulatory-compliant ODM solutions through systematic risk management and rigorous processes.
ISO 9001 is the internationally recognized standard for quality management systems across all industries, focusing on continuous improvement, customer satisfaction, and process quality.
Through this certification, we continuously elevate our operational quality standards, fulfilling our responsibility as a highly reliable ODM partner that accurately meets customer needs.
K-CGMP is a standard established by the Ministry of Food and Drug Safety (MFDS), outlining systematic management requirements for all stages, including raw materials, facilities, manufacturing processes, and quality inspections.
Through K-CGMP certification, we possess a state-certified safety and quality management system, strictly adhering to standards to produce cosmetics of consistent, exceptional quality.
The US FDA's MoCRA (Modernization of Cosmetics Regulation Act), enacted in 2022, mandates the registration of cosmetics manufacturing facilities and ensures product safety. Raphas operates manufacturing facilities that fully comply with MoCRA standards, allowing us to seamlessly support relevant certifications for products targeting the US market.
Furthermore, Raphas is the world's first to obtain US FDA OTC (Over-The-Counter) drug approval for a microneedle product, officially recognizing our medical-grade safety and efficacy beyond ordinary cosmetics. We deliver highly reliable and innovative products to the global market.
Global Client Audit Track Record
As an enterprise with its own specialized cosmetic manufacturing facilities, Raphas has successfully met the stringent quality control standards and passed the rigorous on-site audits of major domestic and international partners. Experience the excellence of Raphas' high-quality manufacturing facilities, recognized by the world's most trusted brands.
Global Export Registration & Compliance Support
for Our Partners
We possess extensive experience in product registration and regulatory compliance across various countries to support export enterprises and global partners. Having successfully executed numerous registration procedures in major markets—including MoCRA (US), CPNP (EU), SCPN (UK), and NMPA (China)—we offer comprehensive practical expertise in document preparation, safety assessments, and technical dossier compilation tailored to each nation's specific regulations.
Leveraging this profound experience, we seamlessly facilitate our partners' entry into overseas markets, providing highly reliable product development and registration services that fully satisfy the complex regulatory requirements of each region.