SCG briefing for TFDA Cosmetic
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Transcript of SCG briefing for TFDA Cosmetic
About SCGSinew Consulting Group
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About SCGAbout SCG
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Our PhilosophyOur Philosophy To help our clients to be leaders by providing key information
and sinewy strategiesTo work with our clients as long-term partners with passion
and motivationTo provide our clients a full range of services (total solution)
through professional network, through our expertise and the expertise of other professionals
To become the sinew competence provider for the livelihood industries
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Unique FeaturesUnique Features
Partners： *Research units : FIRDI, ITRI, BPIPO, NBIC, ATIT *NGO units : STEA, HCT, CHCA *Commercial units : Smart Tech, Yet2.com, Tynax Co.,
CAMO Co., KFT Co., LTN Co., NineSigma, Inc.,CEWay Co., Ankang Health Care Co., Bio-Alpha
‧Professionals in livelihood Science, Sensory Science, IP Management, and Market Research
Own the most experiences in practical with livelihood industries ‧in Taiwan, as well as in Mainland China
Hold wide connections with both local and international academic/‧research professionals, as well as livelihood industries related people in Great Chinese Areas (TW, CN, HK)
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The Way We DoThe Way We Do
‧Systematic thinking and design
Enthusiastic‧ and motivated partnership
Honest‧ and confidential treatment
Considerate‧ and long-term service
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Do the Right Thing At very Beginning
SINEW RepresentsService of International, Networking, Efficient Working
Provide Key Service at Sinew PointTotal Solution Systematic ThinkingIntegrated Action Customized Serving
Our BelievesOur Believes
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＊ 16 professional consultants- 6 PhD, 8 MS, 2 BS- all with plenty practical experiences- expertise in sensory and consumer tests,
food safety, quality assurance system, nutrition, package, market assessmentprocessing technology, marketing, regulations,Intellectual properties management & trade
TeamTeam
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Services CoveredServices CoveredIndustrial Areas :
Foods & Beverages, Cosmetics & Personal cares, Medical/Health Devices, Agricultural ProductsBiotechnology products, Drugs & Medicals
Geographical Areas :So Called Great Chinese AreasTaiwan, Mainland China, Hong Kong, Singapore
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Services
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Four Focusing Services
SensoryMarketing
Intellectual PropertiesRegulations
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Sensory AnalysisSensory AnalysisR&D
Formula DevelopmentProduct AssessmentProcess Assessment
Life Cycle Assessment
QASensory QC System
Odd DetectionInstrumental Relationship
MarketingConsumer Test
(FGD/CLT/HUT)Advertisement DesignMarketing Research
Sensory SystemsSystem Introduction
Sensory MethodsPanelists TrainingTAF certified Lab
MakeSense Cloud Software
Sensory QC System—On line 、 Factory 、 Cross FactoriesSensory Marketing Design Sensory Analysis—Discrimination 、 Descriptive 、 Preference TestsPanelists Training—Screening & Training
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Market ResearchIndustry SurveyMarket Survey
Consumer SurveyProduct Concept Survey
CompetenceCompetence AssessmentSegmentation/TargetingLife Cycle Assessment
AdvertisementDM Design
Package DesignInternet Advertisement
Specialty Channel
MarketingSensational Marketing
Event MarketingMarketing Plan
Internet MarketingWebsite Design
MarketingMarketing
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IP CommercializationBusiness Plan
Product DesignProduction Line
OEM Search
IP TradeIP Assessment
Trade Platform & MatchingMarket Assessment
Trade Model
IP ManagementIP Profit Model Plan
IP MarketingIP Strategy & layout
Management System Consultancy
Knowledge ManagementRD Management
QA System ConsultancyOrganization Culture
IP Trade Platform—TW 、 CN 、 Asia 、 EU 、 America IPQA—GMP 、 HACCP 、 ISO22000IP Trade—Patent 、 Trade Mark 、 Know-how
IP ManagementIP Management
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IP LawsPatents
Trade MarksCopy Rights
Commercial Secrets
Registration/ComplianceTFDA(TW)-Functional Foods, Cosmetics, Medical DevicesCFDA(CN)-Functional Foods, Cosmetics, Medical Devices
FDA(USA)-Foods, Cosmetics, Medical DevicesEU Authorities-Cosmetics, Medical Devices
Educations & TrainingWorkshops
On-site Training
Training—Public workshop 、 On stie 、 Annual Training PlanRegistration—Legal Agent (Responsible person) 、 Consultancy 、 Annual Maintenance
RegulationsRegulations
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1.FoodGeneral FoodCapsule & Tablet foodPatient Food
Health Food2.Cosmetic
General cosmeticsMedicated cosmetics
3.Medical devices
Service of TFDA RelativesService of TFDA Relatives
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Label Review
1.Ingredient2.Claim & Intend Use3.Relative Standards
General cosmetic
Medicated cosmetics
new material
B Approval Letter*
A Postmarketing surveillance
C Approval Letter*
*Application Fees to Governmental Agency
Flow Flow Chart of Cosmetic Regulation ComplianceChart of Cosmetic Regulation Compliance
7 working days/item
7 working days/item 90 working days(TFDA review)
28 working days/itemmore than 6 month(TFD
A review)
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• Label Review– Ingredient、 Claim & Intend Use、 Relative
Standards• Approval Letter of medicated cosmetics
– Labeling requirements & labeling review.– Prepare the doucument– Summit the application– Respond to official’s response & get Approval Letter
• Approval Letter of new material– Prepare and/or review of product protocol– Prepare and/or review of product information file and applic
ation documents– Propose required lab tests for safety report and functional re
port– Respond to official’s response & get Approval Letter
ItemsItems
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Welcome to Contact
Contact Person：Newton Yau, PhDSinew Consulting Group, Chief ConsultantTel : 886-3-5733684Fax: 886-3-5739579Email : [email protected] or [email protected] : www.e-sinew.com
