一、 Free consultation services:

Chinese pharmaceutical industry is facing a challenge of improving technology and integrating to the world represented by ICH. The whole regulatory systems of Chinese pharmaceutical industry are fully merging with the global regulatory system.

No matter the newly issued GMP regulations for drug manufacture and quality control or requirement of "generic drug consistency evaluation" for drug R&D, all these reforms will bring the fundamental challenge in every aspect of Chinese pharmaceutical industry and also provide the great opportunities for drug development.

During these reforms, whether they are challenges or opportunities, many enterprises generally have to think about these challenges and make lot of efforts.

It is our missions and common tasks to accept these challenges. Based on our 30 years of experiences in global consultation and technical services for pharmaceutical industry, our company is willing to provide valuable assistance in the implementation of drug regulations, management skills, project implementation strategies, implementation of pharmaceutical technology and effectively assist drug company in their daily activity.

The implementation of regulations and updated technology will promote pharmaceutical companies’ development.

See: [Free Consulting Service Model]

二、GMP/EPCM technical service:

Guangzhou WestPoint Pharma Tech Co., Ltd. 

Business: 

We are a major company in China that has focused on EU and US GMP consultation over 30 years, and the only project management company that provides EPC service for pharmaceutical company in China.

Achievements: 

With over 30 years experiences and services for GMP consultation and pharmaceutical facility construction (EPC) project, more than 40 manufacture facilities with EU and US standard have been designed and completed, and the GMP system in these facilities have been established.

Performance:

Providing technical and regulatory consulting services in the pharmaceutical field, helping pharmaceutical company to comply with global GMP requirements especially in EU/US and establish modern facility management system;

Services: 

Helping company to establish global GMP system and EPC project with GEP to get EU/US GMP certification. These services include facility design, project construction, management, equipment setting up, GMP system and document system validation and GMP certification at home and abroad. Help pharmaceutical companies to set up manufacture facilities with cost-control and advanced technology and ensure the safety and environmental protection during the construction process and drug manufacture operation to meet global GMP requirements.

三、Product development (CRO/MAH) business:

Dongguan WestPoint Pharmatech. Co., Ltd. 

Business:

China's top CRO company focusing on generic drug R&D and registration in EU/US, and the best project team in Chinese generic drug R&D field.

Performance: 

Our company concentrates on generic drug R&D. The established generic drug R&D system and its manufacture system comply with the global standard such as ICH. All products have been registered in EU, US and China.

Achievements: 

With over 10 years of experience of generic drug and  its registration services in EU and US, our company has completed more than 40 projects of generic drug product research and development and their EU and US registration.

Service 1:

R&D system consulting service: Provide service of generic drug R&D technology, project management, regulatory consultation and training for domestic pharmaceutical companies and help them to establish a high-quality R&D system.

Service 2:

R&D outsourcing service (CRO): Based on our company's global standard R&D system (QbD), we will help domestic company to complete R&D of “generic drug consistency evaluation” and submit for approval. We will also help generic drug companies to register their products in China, EU and US.

Service 3:

Product MAH cooperation: Relying on our broad experiences and advantages in generic drug development, we cooperate with drug manufacturers or sales entities to share both advantages and to establish long-term win-win strategy through MAH cooperation.

四、Pharmaceutical excipients business:

Jiangsu WestPoint Pharmaceutical Excipients Co., Ltd.

Business:

R&D, production and sales of USP and EP grade of pharmaceutical excipients, supplying high-quality excipients to pharmaceutical companies and meet the needs of drug manufacturer after "generic drug consistency evaluation" requirement.

Performance: 

The company's main goal of pharmaceutical excipient business is to provide high-quality and high-performance pharmaceutical excipients and to meet the demand of drug development from domestic pharmaceutical company, so as to replace the same imported excipients. We will help domestic pharmaceutical enterprises to develop pharmaceutical technology, improve product quality and promote the comprehensive integration of domestic pharmaceutical company with the global market.

Products: 

The main products include:

Microcrystalline cellulose (MCC)series,

Pretreated excipient series,

Aseptic excipient series, etc.

Services: 

Based on the strategy of overall integration of Chinese pharmaceutical industry with global pharmaceutical standard, especially the acceleration of research and development through "generic drug consistency evaluation" program, our company, supplying domestic made pharmaceutical excipients, will provide adequate technical support to pharmaceutical companies to complete their transfer from imported to domestic pharmaceutical excipients.  We will conduct relevant drug formulation research and provide filing document and application. We can optimize the drug formulation process and improve the quality of drug products quickly.  All these services will help and promote the drug development for our customers.