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Integrated Preclinical Trials Services

2021-09-29
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COMPANY PROFILE

Shanghai Medicilon Inc. is one of the top contract research organizations (CRO) in China. Since its establishment in 2004, Medicilon has been striving to offer fully integrated pharmaceutical services for the global scientific community. We have over 1,900 employees cross biology, chemistry and preclinical research. Over 30% of our employees have M.S. and Ph. D. degrees.

Medicilon is a Preclinical Research Outsourcing (CRO) company. With our more than 10 years experience on preclinical research services, we dedicated to provide our clients with customized preclinical services program in drug metabolism, pharmacokinetics, efficacy studies, and toxicology. We provide our clients a high-quality data and rapid turnaround time to support their drug development, preclinical studies and clinical research and to help them to select the most valuable drug candidates into clinical trials stage. Our preclinical research services consist in three major parts: pharmacokinetics, disease transplantation models and drug safety evaluation. Our preclinical research services cover all of the aspects including design, in vivo studies, sample analysis, professional data analysis, IACUC review, and the preparation of application materials.

Medicilon is one of the first CRO in China to provide integrated services, including compound synthesis, biological activity screening, structural biology, pharmacodynamics, pharmacokinetics, toxicology, and IND filing. Our high quality services are well-recognized internationally.

Medicilon is fully accredited by the International Laboratory Animal Assessment and Accreditation (AAALAC) and in compliance with the US Food and Drug Administration’s (US FDA) Good Laboratory Practice (GLP). The standard of laboratories is certified by NMPA for GLP compliance. Therefore, experimental reports generated at Medicilon can be used for China and USA dual filing to facilitate the evaluation of the safety and marketing of life-changing compounds for our clients.

INNOVATION PLATFORM

  • The GLP for Safety Evaluation Platform

  • The Protein and Antibody Pharmacokinetic Platform

  • The Animal Disease Models Platform

  • The Isotopic Platform

  • The Protein Crystallography Platform

  • The New Drug Formulations and The Generic Drug Platform

WHY CHOOSE MEDICILON?

A CRO to Provide Full Set of Preclinical Research Which Comply with Both China and US GLP Standards

A CRO to Provide “Foreign Pharmaceutical Company – CRO – Domestic Pharmaceutical Company” Three Parties Collaboration

A CRO to Provide Structural Biology and Chemical Biology Services

One of the Largest Preclinical Drug Safety Evaluation CRO in Shanghai

CAPABILITIES

Integrated and Comprehensive Drug Research and Development Service Platform

Chemistry Services

Medicinal Chemistry: Drug Design, Structure-Activity Relationship Campaign, Lead Optimization and Druggability Test

Synthetic Chemistry: Intermediates, Reference Compounds, Metabolites, Impurities, and Other Small Molecule Chemicals

Process Development: Development and Optimization of Synthetic Process, Quality Analysis

Biology Services

Recombinant Protein Expression and Purification, Crystallization and Structure Determination, Discovery Biology, SeMET Growth Media Kits and Packages, Computational Biology and Molecular Modeling, Isotope Experiments and Biomarker Testing

Formulation

Solid Formulation: Tablets, Capsules, Granules, Injectable Powder

Semi-Solid Formulation: Ointments, Creams, GelsLiquid Formulation: Injections, Oral

Liquid Preparations, Sprays, Tinctures

Innovative Dosage Forms: Slow Release Formulations, Nano Preparations, Pellets, Fat Emulsions

Pharmaceutical Analysis

API Analysis, Formulation Analysis, Analytical Method Development and Validation, Impurity Studies, Regular Chemical Analysis

Preclinical Services

Pharmacokinetics: In Vivo Assays, In Vitro Assays, BE Research, A Full Set of Studies for IND (CFDA & US FDA)

Drug Safety Evaluation: Single Dose Toxicity Test, Repeated Dose Toxicity Test, Safe Pharmacology Study, Immunogenicity  Test, Toxicokinetics, Reproductive Toxicology Study, Genotoxicity Study

Pharmacology: Oncology, Digestive Diseases, Endocrine and Metabolic Diseases, Inflammation and Immune Diseases, Nervous System Disease Models

Bioanalysis: Small Molecule Drugs, Biologics (Proteins & Antibody)

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