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Service Offering
Regulatory & Ethics Services
We ensure smooth navigation of IEC and regulatory requirements across India. Our regulatory and ethics team supports submissions, documentation, and ongoing compliance so your studies meet ICH-GCP, ICMR, CDSCO, and NDCT standards.
Key Capabilities & Features
- IEC submission, coordination, and continuing review support
- IEC registrations, dossiers, and IRB submissions
- CDSCO, DHR, and CTRI documentation support
- NDCT Rule 2019 compliance
- Informed consent forms and participant information sheets (incl. translations)
- Essential document management and SOP development
- Safety reporting coordination
Let's discuss your study
Get a free consultation tailored to your protocol. Our experts will outline how OZAS can support your trial from start-up to close-out.
Let's Discuss Your Next
Clinical Research Project
Partner with OZAS Clinical Services to transform research opportunities into meaningful outcomes. Tell us about your trial, registry, or manuscript — we'll respond with how OZAS can support it.
Or email us at Contact@ozasclinicalservices.com