Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
REG
Regulatory Affairs Support
We provide expert assistance with DCGI submissions, import licenses, and regulatory documentation—helping your organization navigate India’s regulatory landscape efficiently.
Comprehensive Regulatory Support for India Trials
We assist your organization with regulatory document preparation, DCGI submission coordination, and compliance support throughout your India trial lifecycle. Our team brings deep expertise in Indian regulatory requirements, helping you avoid common pitfalls and navigate approval processes efficiently.
As your regulatory support partner, we work alongside your team to prepare submission-ready documents, track regulatory interactions, and maintain compliant trial conduct across all phases.
Our approach
How We Support Your Regulatory Submissions
- 01
Requirements Assessment
We review your trial design and determine specific DCGI submission requirements, timelines, and documentation needs for your study.
- 02
Document Preparation
We compile and format all required documents per DCGI specifications, ensuring completeness and regulatory compliance before submission.
- 03
Submission Coordination
We assist your organization with submission logistics, document tracking, and communication with regulatory authorities as needed.
- 04
Ongoing Compliance
Throughout your trial, we support amendment submissions, annual reports, and other regulatory obligations to maintain compliance.
Deliverables
What You Receive
Submission Packages
Complete, DCGI-ready submission packages with all forms, documents, and supporting materials properly compiled.
Regulatory Checklists
Comprehensive checklists ensuring all DCGI requirements are met for your specific trial phase and study type.
Query Responses
Professional responses to DCGI queries with supporting documentation and clarifications as required.
Tracking Reports
Regular status updates on submission timelines, query status, and regulatory approval progress.
Amendment Dossiers
Properly formatted amendment submissions for protocol changes, investigator updates, or other modifications.
Annual Reports
Compliant annual status reports and other periodic regulatory submissions as required by DCGI.
Why Prequel
The Prequel Advantage
India Regulatory Expertise
15+ years navigating DCGI processes with deep understanding of India-specific requirements and best practices.
Faster Approvals
Complete, compliant submissions reduce query cycles and accelerate approval timelines significantly.
Regulatory Intelligence
Stay updated on changing DCGI guidelines, new requirements, and regulatory trends affecting your trials.
Quality Assurance
Independent review of all regulatory documents ensures accuracy and compliance before submission.
By The Numbers
- 15+ Years DCGI Experience
- 48h Document Review Turnaround
- 100% Compliance Focus
*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
First India Trial
You’re entering the India market and need guidance on DCGI submission requirements, timelines, and documentation for your first trial.
Complex Submissions
Your trial involves novel therapies, complex designs, or special populations requiring detailed regulatory expertise and documentation.
Resource Constraints
Your regulatory team lacks capacity or India-specific expertise to prepare and manage DCGI submissions alongside other markets.
Query Management
DCGI has raised queries on your submission and you need expert assistance preparing comprehensive, compliant responses quickly.
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 Navigate India’s Regulatory Landscape?
Let’s discuss how our regulatory affairs support can help you achieve faster, compliant approvals from DCGI.