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Research on Quality Control

Home Service Research on Quality Control

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 CFDA guidelines.

Research on Quality Control

The development and validation of analytical method

Develop and validate the analytical method according to the features of dosage form and the APIs.

  1. Method Validation for Enantiomers
  2. Method Validation for Impurities
  3. Method Validation for Content Uniformity
  4. Method Validation for Assay
  5. Method Validation for Microbiology
  6. Dissolution Method Validation

Quality Research of The Products

Quality research base on the character of dosage form and compound and relevant guideline.

  1. Identification
  2. Assay
  3. Enantiomers
  4. Related Substances
  5. Disintegration
  6. Dissolution
  7. Dissolution Curve (12 units/lot)
  8. Moisture or Loss on Drying.
  9. Microbiological Test

Determine the specification for final products

  1. Analytical Reports
  2. Protocol of Quality Standard

Stability Study

  • Accelerated and long-term stability test based on ICH guidance and CFDA guidance
  • Forced Degradation Testing
  • Accelerated Stability Test
  • Long-term Stability Test

Consistency Evaluation

  • The development and validation of analytical method
  • Consistency evaluation of formulation by quality specification
  • Make solution base on evaluation result

IVIVC of the Product

We provide the service of IVIVC of the product.

Registration and Submission

  1. Data Processing for the Registration Dossier
  2. Compiling and Translation of the Registration Dossier.
  3. Registration & Submission

Our CMC experts with decades of experience are familiar with various ICH and CFDA regulations and guidelines. We have helped many clients to complete their pre-formulation and formulation studies and provided reliable data for the regulatory submissions. We have already successfully assisted many clients to complete the 1.1 class, 3.1 class and 6 class new drugs for CFDA application.

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  • Formulation Development
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Shanghai Medicilon Inc.

Address: No. 585, Chuanda Road, Pudong, Shanghai, 201200, China
Email: Marketing@medicilon.com
Website: www.medicilon.com

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  • Home
  • About
    • Medicilon Overview
    • Executive Team
    • CEO Message
    • Corporate Culture
    • Company History
    • Honor
  • Services
    • Integrated Projects
      • Antibody-Drug-Antibody (ADC)
      • Preclinical Research Services
      • IND Filing
      • Bio Drug Development
      • Chemical Drug Development
      • Chemical Compound Druggability Assessment
      • Molecular Imaging & Radiochemistry
      • OINDP Development
      • Preclinical Ophthalmic Research Platform
    • Pharmacology Services
      • Cancer Xenograft Models
      • Orthotopic Models
      • Syngeneic Mouse Models
      • Transgenic Mouse Model
      • Humanized Mouse Model (hPBMCEngrafted)
      • PDX Model
      • Digestive System Models
      • Neurological Disorders Models
      • Metabolic Disease Models
      • Inflammation & Immunological Disease Models
      • Other Disease Models
    • Chemistry Services
      • Medicinal Chemistry Services
      • Synthetic Chemistry
      • Process Development Services
      • Analytical Chemistry
    • Drug Formulation
      • Pre Formulation Development
      • Analytical Development
      • Formulation Development Services
      • Generics Consistency Evaluation
      • Research on Quality Control
      • Clinical Trial Material
      • OINDP Development
    • Biology Services
      • Discovery Biology Services
      • Recombinant Protein Services
      • Computational Biology & Molecular Modeling
      • Crystallization & Structural Determination
      • Kinase Services
      • SeMet Media Sales
    • Bioanalytical Services
      • Large Molecule Bioanalysis
      • Small Molecule Bioanalysis
    • Pharmacokinetic Services
      • In Vivo Assays
      • In Vitro Assays
    • Drug Safety Evaluation
      • Inhalation Toxicity Assessment
  • Customer
    • Customer Reviews
    • New Models of Collaboration
    • Intellectual Property Protection
    • Download Center
  • Careers
  • News
    • Medicilon Events
    • Media Coverage
    • Featured Stories
  • Contact
Medicilon Inc