Our Regulatory Services
Regulatory Strategy & Global Development Planning
Build a practical roadmap for product development and market entry in Korea, the United States, the European Union, and China.
▶︎ Product classification and regulatory pathway assessment
▶︎ Market-specific requirements and evidence gap analysis
▶︎ Nonclinical, clinical, and performance evidence planning
▶︎ Development and registration strategies aligned with applicable MFDS, FDA, EU, and NMPA requirements
Product Registration & Submission Support
Prepare and manage regulatory submissions tailored to your product and target market.
▶︎ Registration of pharmaceuticals, quasi-drugs, medical devices, and IVDs
▶︎ Clinical trial and marketing authorization applications, including IND and NDA submissions where applicable
▶︎ Dossier preparation, review, and submission coordination
▶︎ Regulatory authority communication and responses to review questions
Quality Systems & QA/QC Setup
Establish quality systems that support regulatory compliance and daily operations.
▶︎ Quality assurance, quality control, and quality management system (QMS) development
▶︎ Quality manuals, SOPs, and document control
▶︎ DGMP readiness assessments, QC specifications, and testing strategies
▶︎ Deviation management, change control, CAPA, audit preparation, and staff training
Post-Approval & Safety Management
Maintain compliance and support product safety throughout the commercial lifecycle.
▶︎ Registration maintenance, renewals, and variations
▶︎ Labeling updates and regulatory assessment of product or manufacturing changes
▶︎ Pharmacovigilance (PV) system setup and operational support for pharmaceuticals
▶︎ RPost-market surveillance, vigilance, and safety reporting support for medical devices and IVDs