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CMC Services

Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control, our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and SFDA guidelines.

Feasibility study 

  • Project planning

Synthesis


  • Establish synthesis
  • “Freeze” the synthesis
  • Establish large-scale

Formulation Development


  • Pre-formulation testing
  • Formulation development
  • Process optimization
  • IVIV correlation
  • Scale up

Analytical Development

  • Establish HPLC methods for API, impurities, isomers and drug product 
  • Develop HPLC method for stability testing 
  • Conduct HPLC method validation 
  • Set API and drug product specifications

Stability Study

Perform stability study for API and drug product under ICH & SFDA guidelines

Regulatory Submissions

  • Prepare documentation for regulatory submissions
  • Prepare supporting documentation and data package

Our CMC experts with decades of experience are familiar with various ICH and SFDA regulations and guidelines, and have helped many clients completed their pre-formulation and formulation studies to provide reliable data for the regulatory submissions. We have already successfully assisted many clients completed the 1.1 class, 3.1 class and 6 class new drugs for SFDA application.
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What is preclinical testing?

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Inventory of the three major in vitro pharmacokinetic research methods

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Enzyme Activity Assay Service

  Enzymatic assay Lance Assay Alphascreen Assay Z’-LYTE Assay Adapta Assay Kinase-Glo Assay ADP-Glo Assay Ligand Binding Assay ELISA Assay HTRF Assay Enzyme activity assays  are laboratory methods for measuring enzymatic activity. They are vital for the study of enzyme kinetics and enzyme inhibition. Enzyme units : Amounts of enzymes can either be expressed as molar amounts, as with any other chemical, or measured in terms of activity, in enzyme units. Medicilon provides various  enzyme activity assays  for  kinases , phosphatases, proteinases, deacetylase, peptidase, esterase, and other enzymes. Our line of well-characterized immunoassays and biochemical kits ensures accurate and reproducible results. Enzyme is a  large category of bio-molecules  that catalyze various biological processes including metabolic processes, cellular signaling and regulation, cell division and apoptosis. Enzymatic reactions convert substrate molecules into chemically modified molecules products with high sp
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