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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

The Best You Can Find !

Rosetta a Contract Research Organization for drug development, was incorporated in October 2002 and located in New Taipei City, Taiwan. We offering a high quality and cost-effectiveness service for PK, BA/BE, Phase I study, Bioanalytical, Bridging Study etc.. In highly trained staff and precision instruments, we are capable to provide in-depth support to help our client in drug development.

 

Performance/Experiences

  • Strong educational background/Experienced
  • R&D team/ Experienced operations staffs.

  • Technical capabilities in PK study, BA/BE and Phase I study, Analytical development, Validation method development, Study protocol design and study execution

  • More than 250 pivotal BE study projects have been completed

  • More than 730 pilot BE study projects have been completed, and more than 30 pilot studies to support first-to-file applications with the US FDA

  • At least 8 Phase I study projects have been conducted.

  • At least 5 BSE (Bridging Study Evaluation) projects have been completed by Rosetta since 2008

Information

  • Bioanalytical Laboratory has been inspected by the TFDA (Taiwan Food and Drug Administration, Ministry of Health and Welfare of Republic of China) in Sep,2013
  • Establish Animal Facility in Oct,2016
  • Bioanalytical Laboratory and Clinical site have been inspected 2nd by the NPCB (National Pharmaceutical Control Bureau, Ministry of Health Malaysia) in Nov,2016

Inspection of TFDA

Cert NO. GLP 1020007

Accredition By NPCB

Cert. No. KGCP/BE 201611