Regulatory delays can stall a study before it starts. Our regulatory affairs team prepares and tracks submissions to the Central Drugs Standard Control Organisation (CDSCO), registers trials with the Clinical Trials Registry – India (CTRI) and coordinates with institutional ethics committees.
Compliant from day one
We align documentation with the New Drugs and Clinical Trials Rules, 2019 and ICH-GCP, respond to queries promptly and maintain complete regulatory files for inspection.
What is included
- Clinical trial applications to CDSCO
- CTRI registration and updates
- Ethics committee submissions and renewals
- Import and export licence support
- Informed consent document translation
- Regulatory intelligence and advisory
Frequently asked questions
How quickly can you deliver feasibility?
We usually deliver a site-by-site feasibility assessment with realistic enrollment projections within five to seven business days of receiving a protocol synopsis under NDA.
Do you support medical device investigations?
Yes. We support pilot, pivotal and post-market clinical investigations of medical devices and in-vitro diagnostics in line with the Medical Devices Rules, 2017.
Can you work with overseas sponsors and CROs?
Absolutely. We regularly act as the local execution partner for international sponsors and CROs, supporting regulatory submissions, site management and monitoring in India.
What does your quality system look like?
We operate under a documented quality management system with SOPs, training records, internal audits, CAPA management and regular mock inspections at sites.