Regulatory Advantage
Regulatory Expertise:
- Regulatory Strategy: Expertise in submission for India, US, EU, China, Japan, Canada, and emerging markets-ROW
- Health Authority Meetings: Preparation support, briefing documents, rehearsals, meeting attendance, and health authority liaison
- Query Management: Internal process to track regulatory queries for countries
- Turn Around Time: Minimal TAT from the time of submission of a process to the time of the completion of the process.
KlinEra Regulatory Approval Track Record:
- KlinEra has office based in Delhi, India to process all Regulatory activities
- Established relationship with regulatory office over a period of 2 decades
- Expertise in navigating through regulatory frame work to obtain approvals in record timelines
- KlinEra has achieved 100% Regulatory Approval during the years of 2012 to 2021
- KlinEra averages 35% of global clinical trials in India