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Customer Reviews

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From Ardea Bio Science

The quality assurance (QA) unit consists of four full time GLP members and members of the QAU attend SQA meetings every year. The QA manager has been RQAP-GLP certified since 2009. A sign at the entrance to the preclinical building identifies it as a GLP area and instructs to comply with all SOPs. Personal protective equipment standards are taken very seriously. All equipment for GLP use is clearly labeled as GLP. Equipment logbooks are maintained near each piece of equipment and all equipment records from previous years had been archived at the time of inspection. Pipettes are calibrated quarterly. Instruments in use for GLP formulation analysis are all indicated the last date of maintenance and calibration and show the next dates due – labels are firmly secured to the equipment and instruments. In the event of power failure, power is switched to generators within 10 minutes. Temperature and humidity in the test article storage room are monitored by a biannually calibrated thermo hygrometer. Sample storage environmental monitoring performed using SENSATRONICS.

The Medicilon archive meets regulatory expectations for security. The room is locked, it is accessible only by the archivist and entry to the room is tracked with a sign-in sheet. The Archive is protected by a water sprinkler system and archived materials are protected from water damage in plastic bags. Electronic archived materials are stored on CD/DVD in metal boxes locked in a separate cabinet, but within the same room. Pest control material is dispersed among the cabinets. Annual GLP refresher training is performed; training records are maintained in the group leader’s cabinets. Deviations from the SOPs and protocol in the reviewed method validation were properly documented and the impact appropriately addressed by the study director. QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately.

Quality Control & Assurance
QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately.
Ardea Bio Science
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ardea

From SK Life Science R&D Park

The results of an intensive three days audit onsite of GLP systems and procedures, as well as site and personnel, operating systems and procedures and raw data and final report from one non-GLP study lead to the conclusion that Medicilon is qualified and capable of conducting non-clinical GLP studies in compliance with the US FDA GLP. The personnel who participated the audit were knowledgeable and professional. The results of an intensive three day audit as well as facilities and training records and procedures lead to the conclusion that the facility is qualified and capable of conducting in compliance with accepted standards of practice and the GLP.

High Caliber Scientific Staff
The personnel who participated the audit were knowledgeable and professional.
SK Life Science
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sk
Sepracor, (now Sunovion) a biotech company of Boston presented Excellent Performance Award to Medicilon in recognition of excellent services and contributions to its discovery research
Sepracor
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sonovion
Roche R&D China presents a medal of Most Valuable Partner Award to Medicilon in recognition of excellent partnership
Roche R&D
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roche

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Shanghai Medicilon Inc.
Email: Marketing@medicilon.com.cn
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  • Home
  • About
    • Medicilon Overview
    • Executive Team
    • CEO Message
    • Corporate Culture
    • Company History
    • Honor
  • Services
    • 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
    • Biology Services
      • Discovery Biology Services
      • Recombinant Protein Services
      • Computational Biology & Molecular Modeling
      • Crystallization & Structural Determination
      • Kinase Services
      • SeMet Media Sales
    • 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
    • Bioanalytical Services
      • Large Molecule Bioanalysis
      • Small Molecule Bioanalysis
    • Pharmacokinetic Services
      • In Vivo Assays
      • In Vitro Assays
    • Drug Safety Evaluation
    • Integrated Projects
      • Preclinical Research Services
      • IND Filing
      • Bio Drug Development
      • Chemical Drug Development
      • Chemical Compound Druggability Assessment
  • Customer
    • Customer Reviews
    • New Models of Collaboration
    • Intellectual Property Protection
    • Download Center
  • Careers
  • News
    • Our Events
    • Market Activity
    • Press Events
  • Contact
Medicilon Inc