The business covers the fields of medicine, health food and medical equipment.
DST CONSULTING
The business covers the fields of medicine, health food and medical equipment.

Provide overall solutions for GMP in Europe, America, PIC/S, WHO and China, including verification implementation, CSV verification, plant design, QP compliance declaration, MAH system, drug registration and other services.

The business covers the fields of medicine, health food and medical equipment.
DST CONSULTING
The business covers the fields of medicine, health food and medical equipment.

DST DST's business covers pharmaceutical, biotechnology, API, raw and auxiliary packages, medical devices and cosmetics and other industries, and has participated in consulting services for a number of international pharmaceutical projects.

DST International GMP Consulting
DST CONSULTING
DST International GMP Consulting

With the mission of "let more pharmaceutical enterprises reach the international top quality management level", we adhere to the value of "customer first, striver, create win-win" to serve customers.

Website Newsletter:

Warmly congratulate DST Durst and Shanghai well-known radiopharmaceutical companies to reach a plant design project cooperation!

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Warmly congratulate DST Durst on reaching FDA cGMP project cooperation with well-known radiopharmaceutical pharmaceutical companies in Sichuan!

Congratulations on passing! Durst Helps Jiangsu Spectrum New Biology Obtain EU GMP QP Conformance Declaration!

Milestone events! DST DST successfully obtained FDA cGMP plant design project of a biochemical products co., ltd. in Guangzhou

DST experts to Shenzhen well-known pharmaceutical companies to carry out EU and PIC/S projects

Warmly congratulate DST Durst and Shanghai well-known radiopharmaceutical companies to reach a plant design project cooperation!

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Warmly congratulate DST Durst on reaching FDA cGMP project cooperation with well-known radiopharmaceutical pharmaceutical companies in Sichuan!

Congratulations on passing! Durst Helps Jiangsu Spectrum New Biology Obtain EU GMP QP Conformance Declaration!

OUR SERVICES

WeThe service

Our Services

Learn more
Special Services

Special Services

Learn more
QP Conformance Declaration

QP Conformance Declaration

QP Declaration of Conformity is a formal declaration of GMP conformity in the clinical phase of the product in the EU and PIC/S Member States, which has the effect of legal recognition, and the inspection in the clinical phase is equivalent to the official inspection.

Learn More
QP Conformance Declaration
European and American officials accompanied the inspection

European and American officials accompanied the inspection

The European Agency for the Quality of Medicines, the body responsible for the quality assessment of APIs, including: the establishment of standards; the publication of the European Pharmacopoeia and the establishment of European Pharmacopoeia standards.

Learn More
European and American officials accompanied the inspection
Commissioned Audit (Global)

Commissioned Audit (Global)

Commissioned audit is also the third party audit of GMP. Combined with cGMP regulations and appendix requirements, as well as relevant national laws and regulations, the quality management system of pharmaceutical enterprises entrusted to be audited is systematically audited and evaluated, its authenticity, correctness, compliance, legality and traceability are reviewed, and GMP audit reports are issued. Enterprises rectify deficiencies and defects in R & D, production and operation according to the audit reports, ensure the stable and compliant operation of its quality management system.

Learn More
Commissioned Audit (Global)
GMP Audit & Simulated Inspection

GMP Audit & Simulated Inspection

It is a third-party compliance assurance organization, which, in combination with cGMP regulations and appendix requirements, as well as relevant national laws and regulations, systematically audits and evaluates the quality management system of the entrusted enterprise, reviews its authenticity, correctness, compliance, legality and traceability, and issues a GMP audit report. According to the audit report, the enterprise rectifies the deficiencies and defects in R & D, production and operation to ensure the stable and compliant operation of its quality management system.

Learn More
GMP Audit & Simulated Inspection
About Durst

AboutDurst

DST DST is a comprehensive pharmaceutical technology and regulatory compliance consulting company, covering pharmaceutical, biotechnology, API, raw and auxiliary packages, medical devices and cosmetics industries, and has participated in consulting services for a number of international pharmaceutical projects. The Boston branch in the United States provides generic drug and API registration services, and has branches in the United Kingdom and Chengdu, Suzhou, Shenzhen and Zhongshan in China.

Learn more
outlets
SHANGHAI DANSHI BIOPHARMACEUTICAL TECHNOLOGY CO., LTD
ZHEJIANG YAYAN BIOLOGICAL TECHNOLOGY CO., LTD
Kangzhi Pharmaceutical Co., Ltd.
Southern Pharmaceutical
CR Jiuxin
Beijing Kangle Guardian Biotechnology Co., Ltd.
Baiji Shenzhou
Longsha Creatures
Lizhu Creatures
Guangdong Raffles Pharmaceutical Technology Co., Ltd.
Ping An Yanye Yi
Hainan Tianzhuang Nutrient Organics
Agner Biopharmaceutical Limited
Suzhou Yasheng Pharmaceutical Co., Ltd
Chengdu Shengnuo Biopharmaceutical Co., Ltd.
About Durst

GMPTraining

The whole process of GMP compliance service is in place in one step.

When an enterprise establishes a complete and perfect GMP system, it provides the basic conditions for the operation of the enterprise, but if the relevant personnel do not understand the basic ideas of GMP, do not understand the basic principles and processes, it is difficult to ensure the effective operation of GMP, while increasing the risk of errors in audit and inspection. This is also why GMP regulations require companies to ensure that relevant personnel are adequately trained.

Learn more
Picture Name
News

Blog

Learn more
CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

Durst DST Regulation Group, noting that on July 1, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE) issued a trial notice on the submission of electronic application materials for drug registration by network transmission. Starting from July 1, 2024, the trial work on the network transmission of electronic application materials for drug registration will be started, and applicants can submit electronic application materials for drug registration through network transmission. There is also an attachment: the reservation for network transmission of electronic declaration materials and the description of operation steps, which is convenient to guide everyone to submit electronic declaration materials.

2024-07-05

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.

2024-07-05

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.

2024-07-05

Argument! Hengrui Warning Letter, Is It FDA's Political Sanction?

Argument! Hengrui Warning Letter, Is It FDA's Political Sanction?

Tieguai Liu saw many posts about whether there were political factors in Hengrui's warning letter. Today, Tieguai Liu will discuss this matter with everyone's concerns. First of all, we are very sensitive to see that the "first brother" of China's pharmaceutical industry has received a warning letter from the FDA of the United States. For today's Sino-US environment, we naturally think of the FDA's sanctions against the first brother due to the influence of US politics. It is completely understandable from everyone's interpretation. The following Tieguai Liu will discuss with you from both positive and negative dimensions:

2024-10-25

Please collect the sea enterprises! Names and Websites of National and Regional Food and Drug Administration in Southeast Asia (Encyclopedia)

Please collect the sea enterprises! Names and Websites of National and Regional Food and Drug Administration in Southeast Asia (Encyclopedia)

Durst DST continues to pay attention to the drug regulatory policies of countries around the world to help companies go to sea, and the following is the drug regulatory situation in Southeast Asian countries and regions.

2024-10-25

Application of Risk Management in Cleaning Verification

Application of Risk Management in Cleaning Verification

Risk management is a reasonable method to achieve good decision-making, which runs through the whole quality system management, GMP put forward the concept of quality risk management, clear enterprises in the whole cycle of drug production risk assessment. Then, risk management tools are also required for cleaning verification at the source of production, and below the scientifically set allowable residue level, the removal of production product residues or cleaning agent residues from equipment based on risk management methods is an integral part of cleaning verification.

2024-10-25

Industry Dynamics & Knowledge Sharing

Industry dynamics& Knowledge Sharing

Industry Information & Knowledge Sharing

Learn more
Heavy! The General Department of the State Administration publicly solicits the announcement of the "Quality Management Standards for the Production of Pharmaceutical Excipients" and "Quality Management Standards for the Production of Pharmaceutical Package Materials" (draft for comments)

Heavy! The General Department of the State Administration publicly solicits the announcement of the "Quality Management Standards for the Production of Pharmaceutical Excipients" and "Quality Management Standards for the Production of Pharmaceutical Package Materials" (draft for comments)

Durst DST Regulation Group noted that on July 18, 2024, the General Department of the State Drug Administration issued two drafts for comments at the same time, which are on the "Quality Management Standard for the Production of Pharmaceutical Excipients" and the "Quality Management Standard for the Production of Pharmaceutical Packaging Materials". This is the relevant production quality management standard issued by NMPA after the related review of pharmaceutical excipients and packaging materials, requiring feedback through electronic E-mail before August 20, 2024.
The National Drug Review Center issued: Chemical generic injection overfilling research technical guidance notice.

The National Drug Review Center issued: Chemical generic injection overfilling research technical guidance notice.

Durst DST Regulation Group noted that on July 05, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE), in order to further clarify the technical requirements for overfilling research on chemical generic injections and improve the evaluation standard system for chemical generic injections, according to the work deployment of the State Drug Administration, the Drug Examination Center organized and formulated the "Technical Guidelines for Overfilling Research on Chemical Generic Injections", which will be implemented from July 5, 2024
Heavy! CFDI Releases Guidelines for On-site Inspection of Cell Therapy Products (Draft for Comments)

Heavy! CFDI Releases Guidelines for On-site Inspection of Cell Therapy Products (Draft for Comments)

Durst DST Regulation Group noted that on July 12, 2024, the Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as CFDI) issued opinions on soliciting "Guidelines for On-site Inspection of Cell Therapy Products" and feedback through electronic E-mail before July 29, 2024. This is also the second inspection guide on specific drugs issued by CFDI in conjunction with the Special Drug Inspection Center of the State Food and Drug Administration, following the "Guidelines for the Inspection of Radioactive Drug Production" (draft for comments "issued on July 10. The following is the relevant content of the announcement:
CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

Durst DST Regulation Group, noting that on July 1, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE) issued a trial notice on the submission of electronic application materials for drug registration by network transmission. Starting from July 1, 2024, the trial work on the network transmission of electronic application materials for drug registration will be started, and applicants can submit electronic application materials for drug registration through network transmission. There is also an attachment: the reservation for network transmission of electronic declaration materials and the description of operation steps, which is convenient to guide everyone to submit electronic declaration materials.
I want to consult

Consult Now

Professional service team answers

Quickly understand service content

Provide the right solution

Please enter the enquiry and we will contact you immediately

Submit Message
%{tishi_zhanwei}%

Friendship Link

Cooperation

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

Service
Special Services
About
GMP
Blog
Contact

Sweep to identify concerns:

Scan attention consultation

Scan attention consultation

COOKIES

Our website uses cookies and similar technologies to personalize the advertising shown to you and to help you get the best experience on our website. For more information, see our Privacy & Cookie Policy

COOKIES

Our website uses cookies and similar technologies to personalize the advertising shown to you and to help you get the best experience on our website. For more information, see our Privacy & Cookie Policy

These cookies are necessary for basic functions such as payment. Standard cookies cannot be turned off and do not store any of your information.

These cookies collect information, such as how many people are using our site or which pages are popular, to help us improve the customer experience. Turning these cookies off will mean we can't collect information to improve your experience.

These cookies enable the website to provide enhanced functionality and personalization. They may be set by us or by third-party providers whose services we have added to our pages. If you do not allow these cookies, some or all of these services may not function properly.

These cookies help us understand what you are interested in so that we can show you relevant advertising on other websites. Turning these cookies off will mean we are unable to show you any personalized advertising.

License

Powered by www.300.cn SEO | Privacy Policy