ChemSun Research

Innovation in Treatment and/or Prevention of Diseases

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About Us
 
As a specialty contract research organization (CRO), ChemSun Research is committed to the development and commercialization of pharmaceutical, biotech and medical products for the prevention or treatment of diverse disease areas, including mmune, cancer, metabolic, neurological and infectious diseases.

 

          Our R&D services for diverse therapeutics include ...

  • clinical trial site management from Phase I to III, as well as Phase IV for the marketing of products in specific sub-populations, using clinical sites in U.S. and/or Greater China region
  • ethics committee liaison, document preparation and submission, management of approvals
  • regulatory strategy development, liaison and/or representation with regulatory agency, regulatory document preparation and archiving, regulatory submissions, pharmacovigilance reporting
  • outsourcing vendor project management, including project management to meet project timetable 

     

    Our Quality/Compliance services include...

  • GCP/GLP/GMP third-party auditing and monitoring of compliance with regulatory requirements through inspections of CRO, study sites, laboratories, manufacturers, packagers and distribution providers
  • Contract negotiations for Quality Agreements and vendor service agreements
  • Quality/technical assistance for resolution of regulatory agency deficiency and Warning Letters
  • GCP/GMP professional training on-site, in-house with customized learning tools and products, or at our Training Center in Shanghai. 
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    Our Business Development services include...

  • identification and qualification of innovative, potential brand-name, pharmaceutical, biotech and medical candidates from companies across the U.S.-Asia Pacific
  • assistance with due diligence activities
  • assistance with negotiations in licensing deals 
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    As a partner in CHINA / Greater CHINA region, we can contribute to your growth and position as a dominant player in these therapeutic areas in what will become the second largest global pharma market.

     

     

     


Company Team


Our credentials include impeccable research training from world-class institutions, such as the U.S. National Institutes of Health (NIH), over 15 years of experience working in the U.S. pharmaceutical industry, including Big Pharma companies, and U.S. professional accreditation or certification. 


Company culture


Our corporate culture nurtures and promotes innovation, quality, commitment and social responsibility.