Inspection Readiness & Quality Management
Beyond document preparation, we leverage first-hand FDA inspection experience to fundamentally control risks in manufacturing processes and Quality Management Systems (QMS).
- 01.
FDA Inspection Readiness (Pre-audit)
Mock audits and QMS enhancement grounded in the founder's direct inspection experience.
- 02.
Global GMP Advisory
Manufacturing process and supply chain optimisation guidance aligned with ISO 22716, U.S., and European GMP standards.
Policy Analysis & Market Entry
Ad-hoc Services
Use regulatory inquiries, document reviews, and training on demand within contracted hours.
Regulatory Inquiry Response
Individual regulatory issues are reviewed on request from the client.
Labeling & Document Review
Cosmetic-related documents and labelling items are verified.
Training & Advisory
In-house practitioner training and expert advisory services are provided.
Successful global market entry, with Wynngate Korea by your side.
Consult with our world-class regulatory experts to find the perfect licensing strategy for your products.