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Rosetta PharmamateKey for Pharmaceuticals to success

 
Provide best solution Strictly enforce Ethics compliance
Bring most Accurate, Qualified, Efficient and Valuable service

 



Rosetta Pharmamate to be the key for Pharmaceuticals to Professional Area and Head for Success

 

Your Goals is Our Mission

 

Supporting the client in Pharmacokinetic bioanalytical study, BA/BE study,
Bioanalytical testing, Phase I study and Bridging study of drug


Service Scope

Pharmacokinetics and BA/BE Study

Study Protocol Design
Subject Recruitment
Study MonitoringSite Management
Data management
Data Analysis
Biostatistics
Medical writing/Final Report

Bioanalytical

Human Samples
Animal Samples : Rat, Dog, Rabbit
Specimen : Plasma, Blood, Urine, Tissue...
Validation method development

  • Phase I Study

Rosetta’s Phase I study site is via cooperation with Taipei Medical University, and the clinical facilityhas been set up at the Shuang-Ho Hospital (the affiliated hospital of Taipei Medical University)






 

 

 

 



 










 




For Phase I trial environment in Taiwan is required to be conducted in Phase I unit, that must have comprehensive facility, including:

  • Standard procedure for phase I study
  1. Healthy volunteer recruitment
  • Professional full-time study nurse
  • Monitor / emergency equipment
  • Study management

Bridging Study


  • Consultation

  • Regulatory consulting
    Regulatory compliance solution
    IRB submission
    TFDA submission


    Animal Study

    Pharmacokinetics study (beagle dog, mini-pig, rat, mice)
    Development of drug (evaluation of bioavailability)3. Maximum tolerated dose (MTD) test.
    PK study design (blood sampling time,  administration, specimen).
    Pharmacodynamics study (xenograft , nephritis, etc.)
    Animal protocol review.
    Animal housing service
    Investigational new drug (IND) application consultation.