Regulatory Affairs

• Agent of Registration: Involving pharmaceutical product, global Trials

Bio-Product, Diagnostic Reagent, Medical apparatus and Healthcare product

• Regulatory affairs consulting

• Real-Time awareness of changes in Regulatory Environment

• Assurance of Compliance via Internal, Sponsor, and Regulatory Agency audit

Clinical Study Program

• Design of Protocol and CRF

• Evaluation of investigator and study site

• Project Management

• Monitoring of Clinical Study

• Global trial, International multi-center Trials, Study for import drug licenses, Phase I-IV study of innovative drugs, Bio-equivalence tests and Post-marketing surveillance

• Quality Control & Quality Assurance

• Essential documents preparation

• Composition of Study Report

• GCP training and case-study training

• Meeting handling

• Patient recruitment

Data Management

• CRF design and production

• Data management plan

• Database creation

• Patient recruitment

• Double data entry

• Data coding

• Data validation