Compile dossiers per CDSCO Form CTS-01 (NDCT Appendix), including SOPs (ICH GCP 3.1), member CVs (diversity per ICMR 4.2), and training logs.
File via the SUGAM portal; monitor status with biweekly follow-ups; address deficiencies within 15 days.
Support annual renewals (NDCT Rule 9.3), amendments (e.g., membership changes), and reports (SAE summaries per ICH GCP 3.3.2).
Provide EC-specific GCP sessions (ICMR 4.5); conduct self-audits for quorum and conflict rules.
Prepare evidence-based responses to CDSCO queries, targeting approval within 90 days.