Freyr Expertise
- Regulatory Intelligence Support
- Regulatory Due Diligence Support
- South Korea Drug Registration and Approval Process
- Foreign Manufacturing Registration (FMR)
- Marketing Authorization Holder (MAH) / In-country Caretaking
- Active Pharmaceutical Ingredient DMF Filing Services
- Good Manufacturing Practices (GMP) Conformity
- Submission Management to Health Authorities (e.g., MFDS)
- Providing Translation Services
- Data Reliability Inspection
- Planning Timely QMS Inspections
- Reimbursement Application Submission
- Labeling and Artwork Support
- Distributor Identification and Qualification
- Guidance on product registration in South Korea
Coming Soon..,
Affected Products
- cosmetics
- General cosmetic
- Facial cosmetics
- Body cosmetics
- Hair cosmetics
- other
- Functional cosmetic
- Wrinkle free cosmetic
- Whitening cosmetics
- SPF (Sunscreen) cosmetics.
- Hair loss improvement
- Hair dye
- Other functional claims
Services provided
- Support for regulatory information
- Supporting Regulatory product Compliance(formula, ingredients)
- Gap analysis for functional cosmetics
- Safety and Toxicity Assessments
- KPTA notification
- Translation Services
- K-Beauty consulting service
Affected Products
- Nutrient Functional Foods(HFF: Health functional foods)
- General foods
- Novel foods ingredient or food additive.
- Individual Recognized Health Functional Foods(IR-HFF)
Services provided
- Support for regulatory information
- Supporting Regulatory product Compliance(formula, ingredients)
- Gap analysis for novel foods/ingredients
- Safety and Toxicity Assessments
- Foreign Manufacturer registration
- Investigative Services
- Translation Services
- K-Foods consulting service
Affected Products-Daily Chemical Products
- Household chemicals (cleaner, laundry detergents, removers, others)
- Disinfection products (disinfectants, disinfection related products)
- Air freshener products(candles, Indoor perfume or deodorant products)
- Auto products
- Adhesives products
- Others chemical active product(preservative, etc)
Services provided
- Regulatory intelligence & strategy development
- Regulatory compliance assurance for product formulations and ingredients
- Raw material and product safety assessment
- Product efficacy evaluation
- Gap analysis and compliance reviews
- Product registration and notification processing
- Compilation and submission of regulatory dossiers
- Labelling compliance and regulatory review