Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
EC
Ethics Committee Coordination
We manage IEC/IRB submission preparation, tracking, and correspondence on behalf of your organization—ensuring compliant, timely ethics approvals across India.
Comprehensive Ethics Committee Support
We handle the entire ethics approval process on behalf of your organization—from initial document preparation through final approval and ongoing amendments. Our established ethics committee relationships across India and deep understanding of IEC/IRB requirements keep submissions moving.
As your support partner, we integrate seamlessly with your clinical operations team to manage submissions, track timelines, respond to queries, and maintain compliant documentation throughout your trial lifecycle.
Our approach
How We Support Your EC Submissions
- 01
Document Review & Preparation
We review your protocol, ICF, and essential documents, then prepare submission packages tailored to each EC’s specific requirements.
- 02
EC Selection & Submission
Based on site locations and trial needs, we coordinate with appropriate ECs and submit complete packages with all supporting documentation.
- 03
Query Management
We track EC queries, coordinate responses with your team, prepare clarifications, and resubmit revised documents promptly.
- 04
Approval & Documentation
Upon approval, we obtain official letters, maintain approval logs, and ensure all documentation is study file-ready and inspection-ready.
Deliverables
What You Receive
Submission Packages
Complete, EC-ready submission packages with all required documents, forms, and supporting materials.
Tracking Reports
Regular status updates showing submission dates, query status, expected approval timelines, and action items.
Query Responses
Professional, compliant responses to EC queries with all necessary clarifications and revised documents.
Approval Letters
Official EC approval letters, properly filed and tracked for regulatory inspection readiness.
Amendment Packages
Coordinated submission of protocol amendments, ICF revisions, and other updates to all relevant ECs.
Safety Notifications
Timely submission of SAE/SUSAR notifications per regulatory requirements and EC timelines.
Why Prequel
The Prequel Advantage
Faster Approvals
Established EC relationships and proven processes reduce approval timelines by 30-40%.
First-Time Approvals
Meticulous document preparation minimizes queries and increases first-submission approval rates.
Pan-India Coverage
Working relationships with ethics committees across all major trial sites in India.
Inspection Readiness
Documented processes, approval logs, and audit trails support regulatory inspections.
By The Numbers
- 48-72h Average Submission Preparation Time
- 95%+ First-Submission Approval Rate
*Indicative benchmarks from programs we supported as an FSP/vendor; outcomes reflect combined client+vendor execution. Final commitments are documented in the SOW/WO.
When you need us
Common Scenarios
Multi-Site Trial Launch
You’re initiating a trial across 10+ sites in India and need coordinated EC submissions with consistent documentation and timeline management.
Amendment Coordination
Your protocol or ICF requires amendments and you need to submit updates to multiple ECs simultaneously while tracking approvals.
Resource Capacity
Your internal team is at capacity with ongoing trials and can’t dedicate resources to new EC submissions without delays.
India Market Entry
You’re launching trials in India for the first time and need expertise navigating the IEC/IRB landscape and requirements.
Related support services
Pharmacovigilance Support
ICSR intake/processing, E2B checks, QC & medical review support per client safety SOPs.
Clinical Data Management Support
EDC/eCRF build & validation, DMP/edit checks, coding, queries, freeze/lock support.
Ready to Accelerate Your Ethics Approvals?
Let’s discuss how our EC coordination support can help you achieve faster, compliant approvals across India.