Archive for the ‘Regulatory guidelines’ Category

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  Approval audit Audit Report Audits BA BE CDSCO central lab CFR clinical reserach Clinical trials CRO database DCGI DCGI followup Drug Controller Ethics facilities GCP Globalization ICMR India Law Monitoring Need for Audits Pharma Zones in India Phase 0 phase I protocol Register human Clinical trials Regulatory guidelines Schedule Y1 Thirdparty Audits TMF USFDA OFFICE

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  • Schedule Y1 set to check fly-by-night operators in clinical trial sector
  • Now In INDIA, all human clinical trials to be registered.
  • DCGI setting up Pharma Zones in India
  • NEW DIABETES DRUG APPROVED WITHOUT TRIAL
  • ICMR comes out strict draft norms on clinical trials

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