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Industrial Technology Research Institute


GMP Production Platform of Botanical New Drugs for Clinical

Technology Overview

GMP Production Platform of Botanical New Drugs for Clinical/Pre - Clinical Uses.
GMP Production Platform of Botanical New Drugs for Clinical/Pre - Clinical Uses.

ITRI’s GMP–certified pilot plant for botanical drugs and quality analysis laboratory were built to support domestic producers in botanical medicine development. By bringing together experts in pharmacology, botany, nutrition, and chemical engineering, ITRI established a rapid and accurate active ingredient screening platform for plant chemistry research and active ingredient isolation by integrating bioactivity, chemical composition, and multivariate analysis.

Applications & Benefits

ITRI provides services which include natural product R&D and composition evaluation, as well as GMP production scale–up and quality control. Furthermore, ITRI assists in the fields of agriculture, cosmetics, health supplements, Chinese herbal medicine, and plant–derived drugs by providing preclinical research, sample preparations, CMC, and follow–up pharmacological and toxicological evaluations.

One-Stop Biomedical Services

One-Stop Biomedical Services

  • Listing Regulations Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more.
  • Technology Transfer: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology.
  • Model Translation: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more.
  • Preclinical / Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports.
  • Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.