About Durst
ABOUT US
Durst (Shenzhen) Consulting Service Co., Ltd.
Durst (Shenzhen) Consulting Services Co., Ltd. is a comprehensive pharmaceutical technology and regulatory compliance consulting company, covering the fields of medicine, health food and medical devices; it has participated in consulting services for many international pharmaceutical projects. The Boston branch in the United States provides generic and API registration services, as well as branches in the United Kingdom and Chengdu, China.
Durst (Shenzhen) Consulting Service Co., Ltd. (hereinafter referred to as "Durst") focuses on the implementation of international GMP in domestic enterprises and the application of professional pharmaceutical software in the pharmaceutical field, and promotes domestic pharmaceutical enterprises to be in line with international standards. In terms of factory design and construction, equipment and facilities verification and system construction, Durst carries out pharmaceutical factory design, project construction management, establishment of verification system, establishment of GMP document system of Chinese and European and American standards, and systematic personnel training in accordance with international standards.
Based on the deep regulatory knowledge and rich project implementation experience of the company's professionals, Durst ensures the high quality and efficient implementation and execution of the project. Durst has a sound project implementation management system, full of professionals. The company's technical team has rich international GMP knowledge and experience, such as Donato Longo, who has served as GMP inspector in the United States and the European Union, and Diao Tiejun, who wrote GMP guidelines.
Office address in China, including Shenzhen office, Chengdu office, Suzhou office and Zhongshan office.
2021
Established
10000
Registered capital
2000
COOPERATION CUSTOMERS
100
Employee
Our auxiliary European and American GMP certification project: lizhu Monoclonal Antibody (US cFDA), Beida Unnamed Antibody (Overall Design of Factory Area), Shanxi Nuocheng Pharmaceutical (PIC\S Certification), Zhejiang Jingwei Pharmaceutical (US cGMP), Henan Dongtai Pharmaceutical (EU cGMP), Changchun Baiyi Pharmaceutical (EU cGMP Raw Materials and Preparation Computerized System Verification), Anshi Pharmaceutical (China) (EU and US FDA), Shenzhen CNOOC Haidewei (Factory Overall Verification Project), nanxiong Yangpu Pharmaceuticals (API Brazil GMP certification), Guangzhou Baiyunshan Hanfang Pharmaceuticals (European and American GMP system training), Hangzhou East China Pharmaceuticals, Senti Bio project, etc.
Durst helped the national medicine Zhijun pass the EU GMP certification in April 2022, Sichuan Huiyu Pharmaceutical pass the FDA cGMP certification in August, Anhui Longkema Biology pass the WHO certification in October, and an enterprise in Shenzhen successfully pass the EU GMP inspection for non-sterile injections in Germany in November.
In April 2023, it helped Shuode Pharmaceutical to pass FDA cGMP certification, and in August, it helped Shenzhen National Medicine to pass TGA GMP certification.
In September 2023, help Chengdu Shengnuo Biology pass the PAI inspection of FDA cGMP;
In November 2023, Sichuan Huiyu Pharmaceutical was helped to pass the on-site inspection of FDA cGMP. Guangdong Xinghao Pharmaceutical, a customer served by Durst, passed the on-site inspection of FDA cGMP.
The verification projects we have completed in recent years include: lizhu Biological Vaccine Production Line Verification Project (Stock Solution Preparation), Shenzhen Yinuo Micro Pharmaceutical Technology Aseptic Production Line Verification Project, Zhuhai Ruisipuli Workshop Overall Verification Project, Zhuhai Manulife Pharmaceutical Workshop Equipment Verification Project, Hainan Senqi Pharmaceutical Co., Ltd. Workshop Equipment Verification Project, Shenzhen Yinuo Micro Pharmaceutical Technology Aseptic Production Line Re-verification Project, Zhuhai Manulife Pharmaceutical Workshop Equipment Re-verification Project, Longsha Biological Equipment Verification Project, Baiji Biological Equipment Verification Project project, Agner Plant Verification Project, Sichuan First Medical Technology Plant Overall Verification Project.
In terms of computerized system verification (CSV), we have completed a number of CSV verification projects in recent years in pharmaceutical integrated systems, network workstation systems and scientific data management systems, and various stand-alone workstation software in laboratories. We have successively completed computerized system verification services for equipment and systems for customers such as Lizhu Biology, CR Jiuxin Pharmaceutical, Zhuhai Risipu, Corning Jerry, Lianxin Pharmaceutical, Shanghai Danrui Biology, North China Pharmaceutical, etc.
cultural concept
Enterprise purpose
Customer trust, employee happiness, social satisfaction
Teamwork
Encourage cooperation and communication among employees, emphasizing the importance of collective strength and joint efforts
Enterprise Mission
People-oriented innovation for the soul of the management philosophy; customers for the first prompt and thoughtful service philosophy; strict and pragmatic for the enterprise style
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
Sweep to identify concerns:
Scan attention consultation