Regulatory Affairs Support
Dossier preparation, trackers & clarifications; filings done by sponsor/CRO or by us when authorized.
Ethics Committee Coordination
We prepare, track and coordinate IEC/IRB submissions and correspondence on behalf of your organization, with ethics committees across India.
Comprehensive Ethics Committee Support
We prepare and coordinate IEC/IRB submissions on behalf of your organization — from document preparation through query responses, approval tracking and amendments — with the submission made by the sponsor/CRO, or by us where formally authorised. A working understanding of IEC/IRB requirements keeps 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
Site EC Mapping & Submission Packages
From your site list, we identify each site’s registered ethics committee and its requirements, and prepare complete packages for submission by the sponsor/CRO, or by us where authorised.
- 03
Query Management
We track EC queries, coordinate responses with your team, prepare clarifications, and prepare revised documents for resubmission.
- 04
Approval & Documentation
Upon approval, we obtain the official letters, maintain approval logs, and file the documentation to support study-file and inspection readiness.
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 amendment packages — protocol amendments, ICF revisions and other updates — for all relevant ECs.
Safety Notifications
SAE/SUSAR notifications prepared and tracked against the reporting timelines set by the NDCT Rules, 2019 and each EC.
Why Prequel
The Prequel Advantage
Fewer Avoidable Query Cycles
Documented submission processes are designed to cut down avoidable query cycles.
Complete First Submissions
Thorough document preparation is aimed at reducing avoidable EC queries.
Pan-India Coordination
Experience coordinating with ethics committees across India.
Inspection Readiness
Documented processes, approval logs, and audit trails support regulatory inspections.
When you need us
Common Scenarios
Multi-Site Trial Launch
You’re initiating a trial across multiple 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.
Planning Ethics Submissions in India?
Let’s discuss how our EC coordination support can help you prepare complete, compliant submissions across India.