Manufacturing, Quality Inspection, Packaging, Labeling, and Storage for Quasi-drugs and Cosmetics
Your Regulatory and Distribution Partner for Market Entry
We build the optimal market-entry scheme to bring your business plan to life. From highly regulated quasi-drugs to general cosmetics, we provide a reliable operational framework tailored to each product’s characteristics.
- Planning to import and sell overseas products but do not hold the required manufacturing or marketing licenses in Japan.
- Want to outsource the entire process—from ingredient verification to Japanese labeling and final release decision.
- Looking for a trusted facility capable of operating under the strict approval controls required for quasi-drugs.
- Need to outsource detailed operations such as multi-product kitting or promotional set assembly.
Our Services
1. Import and Market Release Support for Quasi-drugs and Cosmetics (Marketing Authorization Holder Support)
As the legally responsible entity, we provide one-stop support for domestic distribution.
Quasi-drugs
Verification and application based on approval details (ingredients, quantities, efficacy, etc.), preparation of statutory labeling, and market release decision.
All processes are managed in accordance with GQP/GVP. Our documentation and record-keeping system is based on ISO 13485 medical device manufacturing standards.
Cosmetics
Ingredient verification, submission of manufacturing/marketing notifications, preparation of statutory labeling, and market release decision.
We apply the same strict quality standards used for quasi-drugs to protect your brand integrity.
2. Inspection and Packaging for Quasi-drugs and Cosmetics(Manufacturing Services: Packaging, Labeling, Storage)
At our licensed facility, we perform inspection, packaging, and labeling operations, delivering products ready for market distribution.
For quasi-drugs requiring temperature control, we support storage environments based on −20°C to 30°C, with flexible temperature management tailored to product characteristics and client requirements.
Labeling & Packaging
Product inspection, creation and application of statutory labels, boxing, and shrink-wrapping.
Kitting & Assortment
Promotional sets, gift assortments, sample inclusion, and other manual assembly operations.
Rework & Repackaging
Replacement of overseas packaging for the Japanese market, inspection, and repackaging.
Integrated Process from Import to Market Release
- Hearing: Product Information
- We review product details, ingredients, and schedules required for market release.
- Document Submission: Product Data
- Clients provide ingredient lists, specifications, test reports, and draft labeling.
- Regulatory Review: Compliance Check
- We confirm regulatory acceptability, labeling requirements, and necessary procedures for market release.
- Procedures: Notifications & Approvals
- Cosmetics: manufacturing/marketing notifications.
Quasi-drugs: approval applications and related procedures.
- Import: Incoming Inspection
- We review manufacturing records for each imported lot and conduct incoming inspections.
- Packaging & Labeling
- Creation of Japanese labeling; statutory labeling based on approval documents for quasi-drugs.
- Release Decision & Market Distribution
- Lot conformity is verified under GQP, and products are approved for market distribution.
Quality Management System
Our operational framework is based on ISO 13485 medical device quality standards and is fully applicable to quasi-drug and cosmetic processes.
Traceability Assurance
We maintain complete records—from lot control of incoming products to packaging materials used and final release decisions—ensuring rapid investigation in the event of any issue.
Collaboration Between Marketing Authorization and Manufacturing Functions
Both the marketing authorization function (responsible for release decisions) and the manufacturing function (packaging, labeling, storage) are located at the same site.
This enables immediate verification of specifications and approval details, preventing discrepancies even in multi-product or small-lot operations.
Our Strengths — Why Clients Choose Us
1. Shortened Lead Time Through Integrated Operations
From import consultation to final release decision, all processes are completed at a single site, minimizing inter-process delays and enabling stable market supply.
2. Rigorous Quality Management for Quasi-drugs
With an ISO 13485–certified manufacturing site, we maintain strong compliance standards that support your brand—whether for quasi-drugs or cosmetics.
3. A Partnership-Driven Operational Model
We do not own our own brand and specialize exclusively in contract operations. As a neutral outsourcing partner, we provide stable and reliable support for your product supply chain.
Tell Us About Your Needs
We welcome early-stage consultations such as “Is this case feasible?”
From building practical operational schemes to estimating costs, we respond flexibly to your requirements.
- Converting overseas packaging into Japan-compliant packaging under the Pharmaceutical and Medical Device Act.
- Repackaging or relabeling imported products for the Japanese market.
- Outsourcing only the marketing authorization function, including regulatory management and release decisions.
- Inspecting imported products for damage and replacing packaging to maintain brand value.
- Outsourcing small-lot labeling or multi-product assortment operations.
