Fast IRB/IEC and Local regulatory (JFDA) submission and decision.
Triumpharma has successful history of JFDA inspections, USFDA, ANSAM (French National agency for Medicines and health products safety), Bfarm (Federal Institute for Drugs and Medical Devices (German)), EMA: Austrian Federal Office for Safety in Healthcare (Bundesamt für Sicherheit im Gesundheitswesen, BASG) and Health and Youth Care Inspectorate – Pharmaceutical Affairs (Netherlands)), Turkish MOH, GCC and UAE-MOH”.
We have very strong experience for conducting USFDA studies. The report will be prepared in Electronic Common Technical Document (eCTD) format in compliance with FDA regulations and CDISC requirements.
| Regulatory body | Approval | Time (for Clinical) | Time (For BE/BA) |
|---|---|---|---|
| IRB/IEC | IRB/IEC approval by various sites | < 1 week | 3 days |
| JFDA (MOH) | Average regulatory approval for study conduct | 2-4 weeks | 2 weeks |
| Total | 3-5 weeks | 2-3 weeks |