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