QUASI-DRUG OEM
We will examine the feasibility of making it a quasi-drug and identify the necessary requirements.
Review the intended efficacy and effects, active ingredients, labeling, and manufacturing conditions to determine whether proceeding as a quasi-drug is appropriate.
FIRST CHECK
Quasi-drugs are not simply a higher-tier version of cosmetics.
For quasi-drugs, the approved indications and effects, active ingredients, formulation, labeling, manufacturing methods, and other elements must be reviewed as a whole. Simply incorporating active ingredients does not mean a product can be sold as a quasi-drug.
Depending on the intended purpose of the product, it may be more appropriate to proceed with it as a cosmetic.
REGULATORY CHECK
Four Key Checks for Quasi-Drugs
Active Ingredients & Formulation
We will consider a prescription in accordance with the indications and effects.
Efficacy and Indications
The display will be adjusted within the permitted range.
Application and Approval Requirements
We will check the necessary procedures and requirements.
Manufacturing Conditions
I will check the quantities, materials, and schedule.
PRODUCT DIRECTIONS
We will clarify the direction of the medicated product to suit your objectives.
Requirements vary depending on the product category and desired benefits or effects. The following is not a fixed list of eligible items, but rather an example provided to help clarify the general concept.
Examples of products and benefits you can consult us about
- Medicated Skincare
- Medicated Cleansing and Cleaning Products
- Medicated Scalp & Hair Care
- For other products, please check individually.
INITIAL CHECK
The initial review leads to sustainable development.
Based on the product's purpose, intended use, desired benefits and effects, active ingredients, labeling, quantity, and time of sale, we will confirm the requirements for it to be classified as a quasi-drug.
OEM PROCESS
Moving toward commercialization through repeated verification.
The process and timeline vary depending on the product category, formulation, and required procedures. We will review the requirements and determine a feasible approach.
01
Consultation & Clarification of Objectives
We will confirm the purpose of the product, desired benefits and effects, dosage form, quantity, etc.
02
Confirmation of Eligibility Requirements and Procedures
We will organize the active ingredients, formulation, labeling, necessary procedures, and manufacturing conditions.
03
Formulation Review & Prototyping
Based on the confirmed conditions, we will proceed with formulation review and prototyping within the feasible scope.
04
Proceed to production after completing the necessary checks
After completing the necessary confirmations and procedures, production will proceed based on the finalized specifications.
IMPORTANT NOTES
Cosmetic OEM varies in terms of duration, cost, and conditions.
For quasi-drugs, in addition to considering the formulation, it is necessary to organize the active ingredients, efficacy and effects, labeling, required verifications, and procedures. For this reason, the development period may be longer than that of general cosmetics, and prototyping costs and compliance requirements may differ.
Please review the following in advance
- The development period varies depending on the product.
- Separate fees may apply for prototyping, verification, and processing.
- This does not guarantee support for or realization of all concepts.
- I will organize the product categories and display details while checking the conditions.
NEXT STEP
We will confirm the requirements for approval as a quasi-drug.
Based on the product's purpose and desired benefits or effects, we will determine the necessary requirements and the best approach.
Things to confirm first
- Intended benefits and effects
- Intended active ingredients
- Product Category and Sales Period
- Preferences for Quantity, Container, and Labeling