Ethics Committee Coordination
Document readiness, submissions & responses in coordination with sponsor/CRO.
Regulatory Affairs Support
We provide expert assistance with CDSCO submissions, import licences, 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, CDSCO submission coordination, and compliance support throughout your India trial lifecycle. Our team brings a working knowledge of 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 support compliant trial conduct across all phases.
Our approach
How We Support Your Regulatory Submissions
- 01
Requirements Assessment
We review your trial design and determine the specific CDSCO submission requirements, timelines, and documentation needs for your study.
- 02
Document Preparation
We compile and format the required documents to CDSCO requirements, checking completeness 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 submission packages prepared to CDSCO requirements, with forms, documents, and supporting materials compiled.
Regulatory Checklists
Checklists mapping the CDSCO requirements for your specific trial phase and study type.
Query Responses
Professional responses to CDSCO 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
Annual status reports and other periodic regulatory submissions as required under the NDCT Rules, 2019.
Why Prequel
The Prequel Advantage
India Regulatory Expertise
Experience with CDSCO processes, and a working understanding of India-specific requirements.
Fewer Query Cycles
Complete, well-prepared submissions are aimed at reducing avoidable query cycles.
Regulatory Intelligence
Stay updated on changing CDSCO guidance, new requirements, and regulatory trends affecting your trials.
Quality Assurance
Independent review of regulatory documents before submission, checking accuracy and completeness.
When you need us
Common Scenarios
First India Trial
You’re entering the India market and need guidance on CDSCO 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 CDSCO submissions alongside other markets.
Query Management
CDSCO 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 prepare complete, compliant CDSCO submissions.