www.wisecompany.org

Wise Co., Inc. is a young, enthusiastic, rapid extending, and fast growing regulatory consultation firm in South Korea.  

One thing we would like to let you know is, 

We know about medical device and cosmetic certification, registration, approval, whatsoever.  

We have considerable experience with U.S. FDA, CE (European), Russia (Customs Union), Thailand, and Korea.

Call us, email us, let us know what you are curious about.

Let us provide you our quotation with other detailed information that might save your time and money.

We have foreign customers who have never met us in person, but are satisfied with our service quality. We are willing and able to provide you proofs that we are entitled in doing what we are doing.

Besides, is consultation cost too high in your country?

Try Korean consultant. You know Koreans work hard.  

Business Area 

Medical Device

• CE MDD
• MFDS (Former KGMP)
• U.S. FDA (Except for PMA)
• China (Very difficult to foreign manufacturers around these days)
• Russia​

Cosmetic

• CPNP (European)
• ​U.S.FDA
• MFDS (Korea)
• Russia (Customs Union)
• TFDA (Thailand)
• China (Very difficult to foreign manufacturers around these days)
• Ukraine

Other services

• Responsible Person (CPNP, European Cosmetic)
• CE MDD (EC Representative)
• U.S. Agent (U.S. FDA medical Devices)
• Food (U.S. FDA)
• GUDID
• GMDN
• 2nd and 3rd party audit for QMS.
• Free Sales Cert

The post SOUTH KOREA appeared first on CE.way.

Taiwan and China Sinew Consulting Group is a Taiwan based company. They offers services in 4 different areas: sensory analysis, marketing, intellectual property (IP) management and regulatory compliance.

REGULATORY COMPLIANCE/REGISTRATION SERVICES

You will need to comply with the regulations for the market that you plan to get into.

SCG provides Regulation Services in Taiwan and Mainland China for the industries of Functional foods, Cosmetics, Personal cares, and Medical devices. The regulations are different in Taiwan and Mainland China as they are governed by different governments. The products in Taiwan will be regulated by TFDA as the ones in Mainland China will be regulated by CFDA.

Service Items :

• Cosmetics/Personal cares registration with TFDA
• Medical devices registration with TFDA
• Functional foods/Foods certification/approval with TFDA
• Cosmetics/Personal cares registration with CFDA
• Medical devices registration with CFDA
• Functional foods certification/approval with CFDA

Methodology :

1. Classify your products
2. Set up consignment relationship
3. Compile the product information documents
4. Experts review
5. Notification
6. Dialogue with officials
7. Registration/Approval

Advantages :

1. All compliance will be conducted by the experts in each category (Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices).
2. All information documents will be controlled with SOP and kept confidential during the whole process.
3. Team members have expertise and plenty experiences to review necessary documents, properly suggest to the consigner, and properly dialogue with local officials.

We can help you to comply with the regulation as a team.

MARKET & INDUSTRY RESEARCH

You will need to learn the truth for the market that you plan to get into.

We will help you to find the truth.

SCG provides Market Research in Taiwan and Mainland China for the industries of Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices.

Service Items :

• Industry environment & market analysis
• Consumer survey (tendency & behavior)
• Product concept survey (response)
• Competitor analysis
• Competence analysis

Methodology :

1. Questionnaire via e-system, email, post mail
2. Telephone interview
3. Face to Face interview

Charged Fee :

It will depend on the scope of the survey.

Advantages :

1. All survey will be conducted by the experts in each category (Foods, Functional foods, Cosmetics, Personal cares, Agricultural Products, Medical devices) compare to common market research companies.
2. All variables will be controlled with SOP during the whole survey conduction process, including the survey design, questionnaire design, target screening, data collection, and data management.
3. Data will be analyzed with proper statistical methods if needed.

We can help you to find the truth as a team.

The post TAIWAn and CHINA appeared first on CE.way.

www.drsaratal.com

Dr. Sara Tal has been engaged in the regulation and registration of cosmetic products in Israel since the year 2000. She has founded and managed the Israel Cosmetics Registration Department at Aminolab for over ten years. Several years ago, she started an independent business in the same field. She employs five people at her office in Rishon Le’Zion, who show skill, professionalism and seriousness and are fluent in Hebrew and English.

The Ministry of Health in Israel has been working on implementing a new regulation for cosmetic products; mainly switching from pre-market registration to in-market control, similar to the regulation in Europe since July 2013.

Once in place, Dr. Sara Tal will represent local manufacturers and importers and will act as your Responsible Person in Israel. The new law is planned to come into action at the latest at the end of the 3rd quarter of 2017.

The service includes:

• They make shore that the products that are marketed in Israel in compliance with all the regulatory requirements, as stated by the Ministry of Health, while making sure that the products are safe for use.
• Preparation of PIF (Product Information File) for each product according to the requirements of the Ministry of Health: production method, compiling information on raw materials, composition of formula, verification of no animal testing, marketing claim review, packaging and labeling of the product etc.
• Guidance for performing microbiological and chemical analyses, as well as stability and challenge test.
• Notification of products as required by the Ministry of Health and ensuring that the products of interest will be placed and circulated in the market without any problems.
• Keeping and updating the PIFs during the period that the products are in the market.
• Presentation of the PIFs to the Israeli Ministry of Health upon their request and reporting of undesirable effects.

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