About Hope
——
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.
Focus on medicine development
More than 100+ technology transfer succeeded
Over 60+ invention patents applied
More than 30+ series of products Industrial production
| 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
Overall arrangement of project management department
02
Technical guidance of each professional director
03
Co-responsible for R & D and Deputy Minister
04
Compliance Guarantee of Quality Management Department
05
Information means to improve efficiency
06
Integrated internal periodic review
07
Proactively report to customers on a regular basis
| 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
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
| Experimental Environment
Haibu's existing laboratory covers an area of about 5000 square meters, with reasonable and efficient construction layout. It has set up experimental and management areas such as synthesis, preparation, analysis, stability investigation, research and development of experimental materials, and is equipped with more than 400 sets of advanced experimental equipment.
Experimental environment
Experimental environment
Experimental environment
Beijing Hope Pharmaceutical Co., Ltd.
