Experimental environment
Hope Overview
SINCE 2005
Beijing Hope Pharmaceutical Co., Ltd., established in 2005, is a high-tech enterprise with "chemical drug technology development-Process Optimization-Regulation registration and approval" as its core competence, and has won the title of "China Top 20 Pharmaceutical R&D Company" for several times. Hope Pharma actively builds one-stop service for drug CRO and CDMO, continuously expands its service areas, and establishes good cooperative relations with some leading pharmaceutical companies domestic and abroad.
Hope Pharma has over 19 years of experience in project evaluation, innovation-oriented patent around design, pre-clinical development, clinical trial practice, registration, marker authorization, etc.. Our products involve anti-tumor, anti-depressant, anti-epileptic, anxiolytic, cardiovascular and cerebrovascular, digestive system, respiratory system and other indications.
In finished products, Hope Pharma has accumulated rich experience in technical platforms such as sustained-release dosage, PLM-PtsE preparation platforms, and transdermal drug delivery, and has long-term accumulation for special reaction types (like nitrification, asymmetric catalysis, low temperature reaction) and chiral drugs. Until now, more than 130 technology transform, over 80 registration approvals and 60+ patents has been finished in Hope(including subsidiaries) for past 19 years, and has been rated as a national high-tech enterprise.
Hope Pharma currently has 3 production bases, passed the on-site audit of USFDA and PMDA, and a number of products have obtained CEP certificate and USDMF number, our products well exported to Europe, Japan, South Korea, Taiwan, India and other countries and regions.
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19
yearsFocus on medicine development
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130
+More than 100+ technology transfer succeeded
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60
+Over 60+ invention patents applied
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30
+More than 30+ series of products Industrial production
| 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 four major R&D platforms: "API R&D platform, formulation R&D platform, innovative technology platform and Characteristic 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 Project Managemen 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證000000号
