Global Regulatory Affairs Consulting

K-GMP provides FDA, CFDA, CE Registration Compliance Assistant for Companies in the Food, Medical Device, Drug and Cosmetics Industries



Overseas Support


FDA

FDA?

FDA(Food and Drug Administration) is the national health authority to protect American consumers and the principals to operate National Health Law.

• K-GMP has signed for a strategic MOU with Registrar Corp to expand our expertise to international approval as well as KFDA (Apr. 2013)
• It promotes the fastest access for FDA compliance to 8,000 companies over Food & Beverages, Drugs, Cosmetics, and Medical Devices
• To build up internal DB
- Registrar Corp has been specialized in FDA compliance for 20 years as U.S. FDA Agent
- We have provided FDA assistance for Food & Beverages, Drugs, Cosmetics, and Medical Devices

FOOD
• U.S. FDA Registration & U.S. Agent Requirement
• Food Canning Establishment (FCE) & Process Filings (SID)
• Labeling and Ingredients Review
• Food Contact Substances (FCS)
• U.S. FDA Food Safety Services
DRUG
• New Drug Establishment Registration & Listings
• Drug Labeling and Ingredient Reviews
• New FDA Self-Identification Requirements
• Drug Master File (DMF)
MEDICAL DEVICE
• Medical Device Establishment Registration & Listings
• 510(k) Administrative Review & Submit
• Medical Device Master Files (MAF)
• Label Reviews and Graphic Design
• Certificate of Registration issued by Registrar Corp
MEDICAL DEVICE
• Medical Device Establishment Registration & Listings
• 510(k) Administrative Review & Submit
• Medical Device Master Files (MAF)
• Label Reviews and Graphic Design
• Certificate of Registration issued by Registrar Corp

CFDA

CFDA?

CFDA is the national health authority to protect Chinese consumers and the principals to operate National Health Law.

• K-GMP has signed for a strategic MOU with 北京采瑞医药科技有限公司 to expand our expertise to international approval
• It promotes the fastest access for CFDA compliance to companies over Foods, Drugs, Cosmetics and Medical Devices.
• Our companies with excellent technology dose have a strong competitive edge in the health food sector research and development and registration.

FOOD
• Establishment registration
• Food safety management guides
• Health Food Master File
• Label and ingredient reviews
• Laws & guides updating and import
DRUG
• New drug establishment registration
• Laws& guides updating and import
• Drug label and ingredient reviews
• Drug Master File
MEDICAL DEVICE
• Establishment registration & Listing
• Laws & guides updating and import
• Medical device Master File
• Label reviews
MEDICAL DEVICE
• Cosmetic classification
• IC System registration
• Laws & guides updating and import
• Cosmetic Label and Ingredient reviews
• Component analysis and confirmation

CE

CE?

The principal point of CE marking is to provide a ‘level playing field’ of market requirements across the European Community. Effectively, this removes barriers to trade throughout the European Economic Area, allowing companies free access to markets in all the different countries without having to meet particular local requirements.

• CE.way is a regulatory consultancy firm providing European Authorized Representative and EU Responsible Person services.
• At the core of operations we provide regulatory services primarily for the cosmetics and medical device industries.
MEDICAL DEVICE

AUTHORIZED REPRESENTATIVE SERVICE PACKAGES

• Authorized representative service (EC REP) For medical device
• Authorized representative service (EC REP) For CE certified device

INDIVIDUAL SERVICES

• Medical device / IVD Classification
• Choice of the appropriate conformity assessment route consulting
• Technical file preparation consulting
• Quality management system implementation consulting (ISO13485, ISO9001)
• Processes’ risk management consulting (ISO14971)
• Vigilance system implementation consulting
• Assistance in obtaining the CE certificate
• Guidance on labeling requirements and labeling review
• GMDN code research & verification
• Non-EU regulatory support
• • Translation service
COSMETIC
• Responsible person service packages
• Responsible person service
• Complete EU cosmetics compliance package
• Worldwide package

SERVICE PACKAGES

• PIF preparation, safety assessment & CPNP Notification

INDIVIDUAL SERVICES

• Safety assessment (EU regulation 1223/2009)
• Guidance on labeling requirements & labeling review
• CPNP notification
• Free sales certificates
• Non-EU regulatory support
• Translation service

PARTNERS SERVICES

• CALLAGHAN consulting international professional service
• SINEW consulting group services