Our Services
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 Trials
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
Healthy volunteer recruitment
Professional full-time study nurse
Monitor / emergency equipment
Study management
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.
Unleash Your Drug Innovation
Contact us to help the full potential of your drug development projects with our expert services.