API R&D Platform

High-end system research laboratory

Drug analysis and development platform

Enzyme biocatalysis Technology platform

Marketing Authorization Holder（MAH）

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  API R&D Platform

  Teamwork, Ability

  API R&D Department of Brightgem Bio-tech has an experienced research management team and a well-equipped research and development laboratory, which can provide a complete set of process research services from process design, pilot route development, medium-scale, process optimization to commercial production, and complete the synthesis research of small molecular compounds from milligram to kilogram.

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  High-end system research laboratory

  Advanced, High-end

  We are committed to the research and development and production of sustained-release preparation products as the core, and continue to develop high barriers and difficult to copy preparation varieties, to meet the domestic and foreign market demand.

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  Enzyme biocatalysis Technology platform

  Environment protecting, High efficiency

  We have a whole system of enzyme-catalyzed reactions
  Batch screening process suitable enzymes, design enzyme reaction path, optimize the process
  It can be used for process amplification and commercial batch production from gram to kilogram.

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  Drug analysis and development platform

  Professional, compliance

  Our analytical research and development team can provide a full range of analysis and testing support for THE R&D and production of API and preparation, from analysis method development, method validation, analysis method transfer to API or preparation testing for the whole process, and in strict accordance with relevant regulations and requirements, to ensure high quality service.

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  Marketing Authorization Holder（MAH）

  International, pioneer, practitioner

  We established MAH certification platform in accordance with the latest national requirements, and established a complete quality management, pharmacovigilance, risk management system. The first drug that passed the consistency evaluation was successfully operated on the platform, striving to become the MAH demonstration platform.