{
  "name": "Life Science Vendor Index Standards & Regulatory Bodies Cross-Reference",
  "as_of": "2026-07-14",
  "count": 8,
  "standards_bodies": [
    {
      "abbr": "EMA",
      "name": "European Medicines Agency",
      "notes": [
        "The EU regulator that reviews clinical trial applications (CTAs) and inspects trial conduct across EU member states.",
        "Reviews statistical methodology as part of clinical trial and marketing authorization applications in the EU."
      ],
      "guide_slugs": [
        "clinical-research-organization-buyer-guide",
        "biostatistics-consulting-buyer-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/clinical-research-organization-buyer-guide",
        "https://lifesciencevendorindex.com/guides/biostatistics-consulting-buyer-guide"
      ]
    },
    {
      "abbr": "EU GMP",
      "name": "European Medicines Agency GMP framework",
      "notes": [
        "Coordinates GMP inspections of manufacturing sites supplying the EU market under EudraLex Volume 4."
      ],
      "guide_slugs": [
        "cdmo-cmo-selection-guide-pharma"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/cdmo-cmo-selection-guide-pharma"
      ]
    },
    {
      "abbr": "FDA",
      "name": "U.S. Food and Drug Administration",
      "notes": [
        "The U.S. regulator that reviews IND applications and inspects trial conduct for GCP compliance under 21 CFR Parts 50, 54, 56, and 312.",
        "Inspects drug manufacturing facilities for compliance with Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Parts 210 and 211.",
        "Reviews statistical analysis plans and submission packages as part of IND, NDA, and BLA review."
      ],
      "guide_slugs": [
        "clinical-research-organization-buyer-guide",
        "cdmo-cmo-selection-guide-pharma",
        "biostatistics-consulting-buyer-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/clinical-research-organization-buyer-guide",
        "https://lifesciencevendorindex.com/guides/cdmo-cmo-selection-guide-pharma",
        "https://lifesciencevendorindex.com/guides/biostatistics-consulting-buyer-guide"
      ]
    },
    {
      "abbr": "FDA / 21 CFR Part 11",
      "name": "U.S. Food and Drug Administration electronic records rule",
      "notes": [
        "The FDA regulation governing electronic records and electronic signatures used in regulated clinical trial data systems."
      ],
      "guide_slugs": [
        "clinical-data-management-vendor-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/clinical-data-management-vendor-guide"
      ]
    },
    {
      "abbr": "ICH E6(R2)",
      "name": "International Council for Harmonisation E6(R2)",
      "notes": [
        "The Good Clinical Practice addendum that sets expectations for computerized systems and data integrity in modern, often decentralized, clinical trials."
      ],
      "guide_slugs": [
        "clinical-data-management-vendor-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/clinical-data-management-vendor-guide"
      ]
    },
    {
      "abbr": "ICH E9",
      "name": "International Council for Harmonisation E9",
      "notes": [
        "The internationally harmonized guideline on statistical principles for clinical trials that most regulatory-grade statistical work is built against."
      ],
      "guide_slugs": [
        "biostatistics-consulting-buyer-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/biostatistics-consulting-buyer-guide"
      ]
    },
    {
      "abbr": "ICH Q7",
      "name": "International Council for Harmonisation Q7",
      "notes": [
        "The internationally harmonized GMP guideline specifically for active pharmaceutical ingredient (API) manufacturing."
      ],
      "guide_slugs": [
        "cdmo-cmo-selection-guide-pharma"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/cdmo-cmo-selection-guide-pharma"
      ]
    },
    {
      "abbr": "ICH-GCP (E6)",
      "name": "International Council for Harmonisation Good Clinical Practice",
      "notes": [
        "The internationally recognized ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that most CROs are contractually required to follow."
      ],
      "guide_slugs": [
        "clinical-research-organization-buyer-guide"
      ],
      "guide_urls": [
        "https://lifesciencevendorindex.com/guides/clinical-research-organization-buyer-guide"
      ]
    }
  ]
}