Services
Regulatory Affairs in India
Navigate the Indian regulatory pathway with a team that prepares, submits and follows up on your applications with CDSCO and ethics committees.
Request a proposal →Clinical trials in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the New Drugs and Clinical Trials Rules, 2019, and must be registered with the Clinical Trials Registry – India (CTRI).
For overseas sponsors, ACRS acts as the local regulatory partner: preparing dossiers, managing submissions and queries, and keeping the study compliant through to close-out.
Approvals
- Regulatory strategy for India
- Clinical trial applications to CDSCO
- Ethics committee submissions and approvals
- CTRI registration
- Responses to regulatory and ethics committee queries
Documents
- Protocol and informed consent adaptation for India
- Investigator brochure and regulatory submission documents
- Patient-facing materials for ethics committee approval
Ongoing compliance
- Safety reporting to regulators and ethics committees within timelines
- Protocol amendments and notifications
- Inspection readiness
Discuss regulatory affairs for your study
Tell us about your protocol, timelines and therapeutic area, and we will suggest how ACRS can support it.