SSY Pharmaceutical Research Institute SSY Pharmaceutical Research Institute

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ORGANIZATION

Introduction

Organization

Equipment

Patent affairs Department

Patent affairs Department

Construct and promote the implementation of enterprise intellectual property management system; Manage all intellectual property activities including conducting patent assessments, drafting IP-related agreements, declaring IPs with government funding, overseeing the preparation of responses to office actions and handling IP disputes; Collaborate with R&D scientists to identify and analyze patented technologies; Monitor competitor patent activity and industry trends to identify potential opportunities and risks; Maintain accurate and up-to-date records of patent filings, and manage other intellectual property-related matters.
Scientific research management Department

Scientific research management Department

Implement the R&D project objectives of the Durg research institution;Control the process of ongoing research projects according to the plan;Monitor the achievement of research objectives;Manage the documents of R&D quality management system;Manage the whole process including import and purchase of reference preparations for research.
Information project approval Department

Information project approval Department

Make annual plan for new product development; Collect information and set up new projects based on market and industry trends, and the company’s development plan;Monitor innovation trends and emerging fields in domestic and abroad to identify advantageous targets and sectors; Manage negotiations, contract signings, in-process coordination and supervision of foreign cooperation projects such as technology introduction and commissioned development.
Registration affairs Department

Registration affairs Department

This department is responsible for the registration and declaration of various new drugs, generic drugs, raw materials, packaging materials, etc.; the change application of document number that has been approved; the supplementary application and the re-registration application. Besides, they should track the approval process, complete related inspection and verification of application, compile and analyze relevant policies and rules.
Quality inspection Department

Quality inspection Department

Conduct risk assessment, risk analysis and quality control during project researching process of the Drug Research Institute, and give suggestions on the common problems existed in documents and research process.Monitor researching process and check related documents, propose corrective suggestions, write reports and follow up the subsequent corrective actions.Manage regular on-site inspections of departments of Drug Research Institution, find out problems and follow up the subsequent corrective actions.Organize the quality training, summarize the project researching problems and on-site inspection problems at a regular interval, put forward assessment results and improvement suggestions.
New drug R&D Center

New drug R&D Center

Relying on the public platform of the Group’s R&D Center and benefiting from rich scientific research resources including a huge number of large-scale instruments, the team is responsible for researching and developing Class I/II new drugs. They are also in charge of the whole process of drug screening and preclinical R&D, including drug design, synthesis, preparation, quality control, pharmacological and toxicological research.Besides, the department participants in the set-up of new drug development projects, conducts technical assessments according to clinical needs to develop products with obvious clinical advantages such as new dosage forms and new drug delivery systems, to determine the research model, to build research platform and to support the Group’s pipeline with its technical superiority.
Liquid preparations R&D Center

Liquid preparations R&D Center

In charge of the development of large-volume injection, small-volume injection, lyophilized preparation, dialysate, inhaled preparation, oral preparation, eye drops, fat emulsion and other products, the department has a National and Local Joint Engineering Laboratory of Chemical Injection Quality Control, the Hebei Large Volume Injection Engineering Technology Research Center, the Shijiazhuang Injectable Drug Delivery System Technology Innovation Center, the Hebei Chemical Aseptic Preparation Industrial Technology Research Institute and the Shijiazhuang Chemical Aseptic Preparation Industrial Technology Research Institute.
Solid preparations R&D Center

Solid preparations R&D Center

Take literature research for the projects and make product development plans according to the Project Task Book;Conduct development and analytical testing of new drugs, including formulation and preparation process, pilot test, process validation and establishment of specifications;Perform technology transfer after the development of new products, and guide the workshop, the technology department and the quality department to complete mass production.Provide technical guidance and service for approved products to workshop, technical department and quality department.Responsible for coordination and exchange of technical cooperation projects.
APIs R&D Center

APIs R&D Center

The team is responsible for the synthesis process development and process improvement of specialty APIs and bulk APIs. Their products cover a lot of fields including anti-tumor, blood lipid, anti-infection, anti-depression and so on. With microchannel reactors, photochemical reaction apparatus, hydrogenation reactors and other equipment, the team have completed process research and development from g’s to kg’s, and have performed process transfer to the factory.At the same time, they conduct the quality and stability study of the APIs, are responsible for the establishment of professional teams and large instrument platforms to develop analytical methods and are in charge of writing materials and declaring patents.
Analysis Center

Analysis Center

This department has a standardized microbiology laboratory, which can conduct comprehensive quality research on drug contents, physicochemical properties, related substances, residual solvents, genotoxic impurities, elemental impurities, bacterial endotoxins, microbial limits, sterility, antibacterial efficacy, etc.
Medical Center

Medical Center

1.New drug clinical department Organize and conduct the clinical trials of new drugs;Compile clinical application documents and registration documents ;Collect the research trends and academic intelligence of similar drugs with the company. 2.Clinical medicine departmentOrganize and conduct the clinical trials of the company, including bioequivalence trials and confirmatory clinical trials;Research and analyze clinical information for the development projects of the R&D center;Compile clinical application documents related to drug registration;Collect the research trends related to drugs in the company’s research list.
Technology Transfer Center

Technology Transfer Center

1.Transfer of technology in manufacturing: Manage the process in which R&D department transfer new products, new processes and new standards to production system and quality system. 2.Transfer of technology in manufacturing related to new products and new process: The content includes production process, key process and key process parameters, suppliers and internal control standards of raw materials and packaging materials, semi-finished products and finished product quality standards, operating conditions of inspection equipment, special conditions of production equipment and facilities, stability data.Subsidiaries