PHDS HEALTHCARE RESEARCH Co., Ltd.
Broadcast Real Star PHDS China CRO Registration Agent
Release time:
2012-12-12
The golden dragon enters the water, the spirit snake emerges from the cave. Beijing Broadcast Real Star Pharmaceutical Technology Co., Ltd. (PHDS) is about to welcome its 12th new year. The company always adheres to the corporate philosophy of 'pragmatism, efficiency, innovation, and progress', and has long upheld the service tenet of 'fully meeting customer needs and creating perfect services', with the path of progress becoming broader and broader.
The golden dragon enters the water, and the spirit snake emerges from the cave. Beijing Boshi Zhi Xing Pharmaceutical Technology Co., Ltd. (PHDS) is about to welcome its 12th new year. The company always adheres to the corporate philosophy of 'pragmatism, efficiency, innovation, and progress' and has long insisted on the service tenet of 'fully meeting customer needs and creating perfect services,' making the path of progress broader and broader.
From the initial focus on domestic clients, including drug registration, health food registration, medical device registration, clinical trials, biological products, vaccines, traditional Chinese medicine, disinfectants, and water-related products; to now focusing on the international field, with clients in 26 countries worldwide, business developments include: import drug registration, import health food registration, import medical device registration, international multi-center clinical trials (Phase I, II, III), import pharmaceutical excipient registration, import drug packaging material registration, food additive and new food resource declaration, and OTC registration.
The registration application document writers at Boshi Zhi Xing (China CRO) have undergone strict professional training and guidance from high-level mentors. They seek guidance from SFDA experts in a timely manner when encountering special issues and seek patient answers from the SFDA review center. The professional registration personnel at Boshi Zhi Xing (China CRO) prepare registration application documents in accordance with the CTD format, fully complying with the technical specifications for drug review, which accelerates the registration process and increases the pass rate.
Boshi Zhi Xing (China CRO) has obtained the international quality system ISO 9001 certification, passing the first initial review and the second monitoring review, and is preparing for the third re-examination. Boshi Zhi Xing (China CRO) strictly implements quality management according to the ISO 9001 quality manual and procedural documents, making project operations more rigorous and standardized, truly meeting international standards.
In 2012, Boshi Zhi Xing (China CRO) revamped its corporate website. The new version of the corporate website is more comprehensive, detailed, and standardized, with clearer and more explicit document editing. The website lists 14 items of company registration services, including: drug registration guidelines, biological drug registration guidelines, medical device registration guidelines, in vitro diagnostic reagent registration, prescription drug registration guidelines, traditional Chinese medicine protection variety guidelines, health food registration guidelines, food additive registration guidelines, new food resource registration guidelines, disinfectant product registration guidelines, water-related product registration guidelines, import food label review guidelines, pharmaceutical excipient registration guidelines, and drug packaging material and container registration guidelines, making it more convenient and clear for customers to consult.
The company is about to welcome a hopeful 2013. Wishing Boshi Zhi Xing (China CRO) continued progress and prosperity, constantly improving the quality of services to provide customers with higher quality first-class services, striving to create an industry-leading brand.
(China CRO PHDS)
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Relevant regulations and policies
Key points and judgment principles for the quality management of non-clinical research of drugs
In order to standardize the on-site inspection work of Good Laboratory Practice (GLP) for non-clinical drug research and improve inspection quality, the "Key Points and Determination Principles for the Inspection of Good Laboratory Practice in Non-Clinical Drug Research" has been formulated in accordance with relevant requirements such as the "Drug Administration Law of the People's Republic of China," "Good Laboratory Practice for Non-Clinical Drug Research," and "Management Measures for the Certification of Good Laboratory Practice for Non-Clinical Drug Research."
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Technical requirements for the latest declaration data electronic disc
In order to further improve the quality and efficiency of the preparation of electronic application materials for drug registration, and to standardize the management of electronic application materials, our center has updated the "Technical Requirements for Electronic Discs of Application Materials" and "Structure of Electronic Documents for Drug Registration Applications" published on December 2, 2022, based on feedback.
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In December 2023, PHDS HEALTHCARE RESEARCH Co., Ltd. was elected as the vice president unit of the China Food and Drug Enterprise Quality Safety Promotion Association, as well as the vice chairman of its subordinate digital professional committee (Certificate No.: Zhong Shi Yao An Cu Hui Zheng Zi 798). The election and award ceremony took place at the Three Gorges Hospital of Chongqing Medical University.
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On March 26-27, 2024, the China Wuxi Global Oral Forum and the China Food and Drug Promotion Association High-Quality Development Conference, guided by the Wuxi Municipal People's Government and the Wuxi Council for the Promotion of International Trade, and organized by the China Food and Drug Promotion Association and the Oral Health Committee of the China Food and Drug Promotion Association, will be grandly held at the Wuxi International Conference Center.
2024-11-22
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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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