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CMC

Committed to the development and innovation of first-class drugs

The pharmaceutical R&D sector of Leadingpharm has established four research institute bases in Beijing, Zhengzhou, Chongqing and Hangzhou. Each research institute has its own characteristics, and its research directions are different in combination with local advantages and clinical needs.

  • 1000Products

    More than 1000 drugs have been developed

  • 500People

    More than 500 professional teams in pharmaceutical R&D section

  • 19years

    19 years of pharmaceutical research experience in applying for drug registration

The scope of services includes:

  • 01
    Study on Synthesis Process of API and Excipients
  • 02
    Research on formulation and technology
  • 03
    Drug quality research and method verification
  • 04
    Impurity customization
  • 05
    Substance detection
  • 06
    Research on special impurities
  • 07
    Compatibility Study
  • 08
    Registration risk assessment and application data writing

National layout

Beijing Research Institute is located in Zhongke Industrial Park. It has a research and development laboratory of 10000㎡ and is equipped with production and testing equipment to support the stage from laboratory to pilot certificate. Among them, there are more than 100 analytical and detection equipment, including HPLC, dissolution instrument, UPLC, GC/GC-MS, LC-MS, ICP-MS, TGA and other large precision instruments.
 

Zhengzhou Research Institute is located in Building 10 of Lifezhengzhou Biomedical Park, with a research and development laboratory of 4000㎡, focusing on the research and development of solid and liquid preparations.
 

Chongqing Research Institute is located in the PSA Science and Technology Park, Yongchuan District. It has a 4000㎡ research and development laboratory, and has a preparation pilot study area, pilot test certificate and scale-up production area, chemical synthesis area, analysis and detection area, and stability setting out area. It can carry out pilot study of high-end solid preparations, external preparations, and trial production of Class Ⅰ， Class Ⅱ innovative drugs and clinical trial products.
 

Hangzhou Research Institute is located in Building 6, Jihua Biological Park, Xiaoshan District, with a total area of 3,000㎡. It is China’s first specialized research institute focusing on pediatric medication, guided by clinical needs, based on various technologies (taste masking, changing the route of administration, etc.), committed to the development of children's preparations and drugs for special groups (e.g. people with dysphagia). Covering traditional Chinese medicine preparations, inhalants, topical preparations, suspensions, microtablets, fine granules, granules, oral liquids, special medical foods and other fields.

 

 

Architecture of the pharmaceutical R&D platform

We has nearly 20 years of experience in the field of API synthesis and preparation R&D, and can provide high-quality API/excipient synthesis process development and impurity customization services, formulation and process development, covers conventional oral drug delivery platforms and high-end drug delivery platforms such as blood brain barrier drug delivery, oral nasal aerosol drug delivery, controlled release drug delivery to skin and mucosa,  targeted drug delivery, etc. A strong R&D team conducts project management in the form of a business unit, emphasizing "professional people focus on professional things", and specially employs well-known experts at home and abroad to form a technical committee to effectively solve project bottlenecks and problems and promote the project to be carried out as planned, can support innovative drug enterprises, MAH holders and generic drug R&D companies to carry out innovative drug/improved new drug R&D, generic drug consistency evaluation and R&D application.

 

 

Pharmaceutical R&D Project Management Mode

① Conference Management Center: according to the characteristics of the project, experts from inside and outside of the company will set up an expert group to check each key node of the project based on the guiding principles and the company's standards, strengthen the whole process control of the project to ensure the smooth application of the project,strengthen the whole process control of the project to ensure the smooth application of the project.
②Technical Committee: Organize and solve technical problems. In response to important technical problems encountered in the project development process, the technical committee organized a team of experts from the company to provide technical support to solve technical problems and ensure the smooth development of the project.
 ③ QA：In the whole process of project research and development, conduct normative inspection of the site and documents to ensure the    reliability and standardization of experimental data and the high-quality pass of on-site inspections.