PHDS HEALTHCARE RESEARCH Co., Ltd.
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Product Registration
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Cosmetic product registration and filing
As a professional consulting and regulatory affairs provider, our services cover the entire lifecycle of cosmetics, from product development to market access, as well as compliance assessment and registration of raw materials, ensuring that your products meet the regulatory requirements of the National Medical Products Administration.
Service Content
Cosmetic Registration and Filing Services
Classification Management:According to the 'Regulations on the Supervision and Administration of Cosmetics', determine whether your product is a special cosmetic or a general cosmetic, and take appropriate registration and filing management measures.
Registration and Filing Person Requirements Review:Ensure that your company meets the qualification requirements for cosmetic registrants and filers, including quality management systems and professional technical personnel configuration.
Application Material Preparation:Assist you in preparing a complete set of application materials, including user information, product information, and other relevant materials.
Cosmetic Raw Material Registration Services
Raw Material Safety Information Reporting:Starting from January 1, 2024, report safety information for all raw materials used.
Raw Material Compliance Assessment:Assess the compliance of raw materials to ensure their safety and regulatory compliance.
Registration and Filing Process Management
Preparation Stage:Assist you in collecting and organizing relevant product information and preparing samples.
Testing Stage:Send product samples to a nationally recognized testing agency for testing in terms of safety, hygiene indicators, efficacy claims, etc.
Registration and Filing Application:Submit applications in the National Medical Products Administration's cosmetic registration and filing information management system and track application progress.
Review Process:Assist you in responding to reviews by the National Medical Products Administration, including verification of paper materials and possible on-site inspections.
Annual Report System Services
Annual Report Submission:Starting from January 1, 2022, submit annual reports for general cosmetics that have been filed for more than one year.
Change and Cancellation Services
Change Management:After product filing, if changes to formulas, production processes, etc., are needed, assist you in promptly reporting to regulatory authorities and applying for changes.
Our Capabilities
| Professional Knowledge:Our team consists of experts in cosmetic regulations and industry consultants who have an in-depth understanding of the cosmetic registration and filing process and regulatory requirements. | Efficient Processes:We have optimized the registration and filing process to quickly respond to and handle various registration matters, shortening your product's time to market. |
| Successful Cases:We have numerous successful cases helping clients smoothly pass through the registration process and obtain cosmetic approval certificates. | Customer Service:We provide one-on-one customer service to ensure that every question you have is answered promptly and professionally. |
Why Choose Us
One-Stop Service:From consulting to registration and filing, we provide one-stop services so you don't have to worry about complicated registration processes.
Professional Team:Our team members have a strong industry background and professional knowledge to provide you with accurate consulting services.
Cost-Effectiveness:Through our professional services, you can avoid time and cost losses due to insufficient material preparation or unfamiliarity with processes.
Continuous Support:We not only help you complete registration but also provide ongoing supervision and management services to ensure your products remain compliant.
'Choose us, and you will gain a trustworthy partner who helps your cosmetic business enter the market smoothly and efficiently. We look forward to working with you to create a beautiful future.'
'Cosmetic Registration and Filing Services'
'Special Cosmetic Registration'
'For special cosmetics such as hair dyeing, perming, anti-hair loss, freckle removal whitening, sun protection, etc., we provide full-service from product formula design, efficacy verification, safety assessment to preparation of registration materials, submission, review follow-up, and collection of registration certificates.'
'Our team is familiar with the registration process and requirements for special cosmetics, ensuring that products successfully obtain registration qualifications to meet market demands.'
'General Cosmetic Filing'
'For general cosmetics, we provide filing consultation, material preparation, submission, and collection of filing certificates.'
'We understand the new policies and requirements for general cosmetic filing and can guide clients through the filing process quickly to ensure products are legally marketed.'
'Annual Report and Change Management'
'We assist clients in submitting annual reports for filed cosmetics to ensure timely updates of product information and compliance.'
'For changes in product formulas or production processes, we provide change application services to ensure that product changes comply with relevant regulations.'
Cosmetic Raw Material Registration Services
'We deeply understand the importance of safety and compliance of cosmetic raw materials for products. Therefore, we provide registration services for cosmetic raw materials including safety assessment, efficacy verification, material preparation, submission, etc.'
'Our team is familiar with the processes and requirements for cosmetic raw material registration to ensure that raw materials successfully obtain registration qualifications providing compliant raw material support for clients' cosmetic products.'
'Registration Person Requirements'
The registrant and record-keeper of cosmetics should be legally established enterprises or other organizations, equipped with a quality management system suitable for the cosmetics they produce and operate, have professional technical personnel related to cosmetics registration and filing, possess the ability to monitor and evaluate adverse reactions, and be responsible for the legality, authenticity, accuracy, completeness, and traceability of the submitted registration and filing materials.
Application materials
Generally, the following materials need to be submitted during registration and filing.
User information related materials:Domestic registrants, record-keepers, and domestic responsible persons should submit the registrant's and record-keeper's information form and the resume of the quality safety person in charge; an overview of the quality management system of the registrant and record-keeper; an overview of the adverse reaction monitoring and evaluation system of the registrant and record-keeper, etc. Foreign registrants and record-keepers also need to submit the domestic responsible person's information form and the original authorization letter from the domestic responsible person along with its notarized copy.
Product-related materials:Including the "Cosmetics Registration Filing Information Form" and related materials, product name information, product formula, standards executed by the product, product label samples, product inspection reports, product safety assessment materials, etc.
Other materials:Starting from January 1, 2024, when applying for special cosmetic registration or conducting ordinary cosmetic filing, registrants and record-keepers must fill out safety information for all raw materials used in the product formula; when applying for registration of spot removal whitening or anti-hair loss cosmetics, it is necessary to submit human efficacy test reports that meet requirements.
Registration and filing processPreparation Stage:Enterprises need to collect and organize relevant product materials such as product formulas, labels, user manuals, production processes, quality standards, safety evaluation reports, etc., and prepare samples. |
Challenges in cosmetics registration and filing
Cosmetics registration and filing typically face several challenges:
Complex regulatory requirements:Different countries and regions may have significant differences in their requirements for cosmetics registration and filing that need to be thoroughly understood and complied with.
Cumbersome registration and filing processes:Cosmetics registration and filing usually require submitting a large amount of material and conducting multiple tests for verification; the process is relatively cumbersome.
High time and cost:Due to the complexity and time-consuming nature of the registration and filing process, significant human resources, material resources, and financial investment are typically required.
The role of CRO in cosmetics registration and filingCRO (Contract Research Organization) plays an important role in cosmetics registration and filing. CROs can provide professional services to help companies complete the cosmetics registration and filing process. Specifically, CROs can provide the following services: |
How to choose a suitable CRO for cosmetics registration and filing
Choosing a suitable CRO for cosmetics registration requires considering several factors:
Professional knowledge and experience:CROs should have extensive experience in cosmetics registration and filing as well as professional knowledge.
Service quality:The service quality provided by CROs should meet industry standards and client expectations.
Communication skills:CROs should be able to communicate effectively with clients to understand their needs and expectations.
Cost-Effectiveness:The services provided by CROs should offer good cost-effectiveness while helping clients achieve their registration goals while controlling costs.
Cosmetics registration is a complex and time-consuming process that requires significant human resources, material resources, and financial investment. CROs play an important role in improving registration efficiency while reducing risks associated with registration. Choosing a suitable CRO requires considering factors such as professional knowledge and experience, service quality, communication skills, and cost-effectiveness.
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Contact Information
Customer service hotline:
E-mail:customer@cnphds.com
Address: Building A, Ocean Express,66 Xia Guang Li, Dong San Huan North Road,Chaoyang district, Beijing, China
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京公网安备11010502056452号