Experimental environment
Hope Overview
SINCE 2005
Beijing Hope Pharmaceutical Co., Ltd., established in 2005, is a high-tech enterprise with "chemical drug research and development" as its core capability.
Hope has over 16 years of experience in project evaluation, innovation-oriented patent around design, pre-clinical development, clinical trial practice, registration, marker authorization, etc.. Project schedule, quality, life cycle, and registration success rate has been ensured under the orderly and well-defined R&D management system. Based on clinical and customer needs, our products related to multiple indications such as anti-tumor, anti-depression, anti-epileptic, anti-anxiety, cardiovascular, cerebrovascular, digestive & respiratory system, and API, oral solid & liquid preparations, injections and so on dosage form included.
Hope has committed to continuously enhancing R & D capabilities, achieved fruitful results in structural modification and transformation of chemical drugs, preparation technology improvement and breakthroughs, synthesis process route optimization and innovation, crystal form challenges. Until now, more than 100 technology transform, over 70 registration approvals and 30+ patents has been finished in Hope for past 16 years.
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16
yearsFocus on medicine development
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100
+More than 100+ technology transfer succeeded
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30
+Over 30+ invention patents applied
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20
+More than 20+ series of products commercialized
| Intellectual Property Management
| Intellectual Property
Management
- Intellectual property evaluation for R&D projects
- Intellectual Property Evaluation & Monitoring in the R&D Process
- Mining & layout of independent intellectual property rights of enterprises
- Patent and trademark application & maintenance & operation & protection
- Enterprise R&D personnel patent training & consulting
| R&D Platform
According to R&D management and customer requirements, Hope has established three major R&D platforms: "API R&D platform, formulation R&D platform and innovative technology platform". Each platform is independently managed according to the type of business undertaken, and the company conducts R&D resources, Unified deployment and coordinated development.
| R&D Project
Management
01
Coordinated arrangements by the Scientific Research Management Department
02
Technical Guidance of Professional Director
03
Joint Responsibility of R&D Director and Vice Minister
04
Quality Management Department Compliance Assurance
05
Informatization Means Improve Efficiency
06
Internal Review of Phase Comprehensive
07
Proactively Report to Customers Regularly
| R&D Quality Management
- In order to ensure that the R&D quality meets the regulatory, Hope has set up a quality management department to be responsible for the compliance of the entire R&D process. The Quality Management Department establishes and maintains a R&D quality system, regulates R&D behavior, audit and manage suppliers and production partners.
- Drawing on the relevant content of GMP and ICH and combining the characteristics of drug research and development work, according to actual needs, We have formulated and strictly implemented multiple R&D quality management systems such as document records, data integrity, employee training, etc. China continuously improves and upgrades the version to control risks, ensure R&D quality, and ultimately achieve the management goal of improving efficiency.
| Information and Data Security
| Informatization and Data
Security
Software Assurance
- Online document management system, setting up dedicated modules for customer projects, and strict execution process
- Agilent and Waters systems conform to the domestic and international double standard data audit trail system, implement three-level password protection, and permanent backup of important data
- Install an anti-leakage system, covering all working computers, and data transfer ring protection
Hardware Guarantee
- Specialized management of server equipment, double backup of important data
- The laboratory sets up access control according to the project and function, and conducts physical isolation
- The monitoring system monitors in real time and supports later tracking
- Work computer internal network operation, no external device
System Guarantee
- Document Management System
- Server maintenance Management System
- Computer Management System
- Monitoring system management system
- Safety Management system
- Confidentiality Management system
- Management system for the transfer of personnel leaving data
| Laboratory
The laboratory covers an area of more than 5,000 square meters. Construction layout is reasonable and efficient. It has set up three professional experimental areas for synthesis, formulation research, Stability study and analysis, with more than 400 advanced experimental equipments.
Beijing Hope Pharmaceutical Co., Ltd. 京ICP备17065299号
