Industries · Kintavo
WHO WE SERVE

Built for the regulated edges the big platforms ignore.

Same Kintavo platform, configured for the rules and rhythms of your domain — from blood banks to cell & gene therapy.

01

Clinical operations & care delivery

3 INDUSTRIES
Healthcare & Health Systems Quality, accreditation, and incident programs that span hospitals, IDNs, and ambulatory networks — without the overhead. TJC CMS CoP DNV Explore Healthcare → Clinical Laboratories CLIA, CAP, and ISO 15189 quality programs purpose-built for clinical, anatomic path, and molecular laboratories. CLIA CAP ISO 15189 Explore Clinical Labs → Blood Banks & Transfusion AABB, FDA, and ISBT-aligned workflows for blood banks, transfusion services, and apheresis programs. AABB 21 CFR 606 ISBT 128 Explore Blood Banks →
02

Development, manufacturing & commercialization

6 INDUSTRIES
Life Sciences An umbrella platform for research, translational, and clinical-stage life-sciences organizations operating under GxP. GxP 21 CFR 11 EU Annex 11 Explore Life Sciences → Pharma & Biotech GMP-compliant quality for branded, generic, specialty pharma, and biologics — built for FDA, EMA, and PMDA scrutiny. 21 CFR 210/211 EU GMP ICH Q10 Explore Pharma & Biotech → Medical Devices ISO 13485 and 21 CFR Part 820 out of the box — with design controls, DHF management, and post-market surveillance. ISO 13485 Part 820 EU MDR Explore Medical Devices → CDMOs Multi-client, multi-product quality systems for contract development & manufacturing — with sponsor-isolated data and reporting. Multi-client Tech transfer GMP Explore CDMOs → Food & Beverage Quality and food safety management for food and beverage manufacturers — HACCP, FSMA, and ISO 22000 on one platform. ISO 22000 HACCP FSMA Explore Food & Beverage → CROs GCP-aligned quality and document control across multi-site, multi-sponsor clinical research operations. GCP ICH E6 (R3) Multi-sponsor Explore CROs →
03

Specialized therapies & tissue programs

2 INDUSTRIES
Cell & Gene Therapy Patient-specific lots, chain-of-identity, and the regulatory rigor that comes with autologous and allogeneic therapies. Chain-of-identity Per-patient lots FACT / JACIE Explore Cell & Gene → Organ & Tissue Tissue banks, transplant programs, and biorepository compliance — built for the chain of custody these programs demand. AATB 21 CFR 1271 UNOS / OPTN Explore Organ & Tissue →

Don't see your industry? Kintavo is configurable to any GxP-regulated environment. Talk to us about your specific compliance scope.

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Whatever framework governs your work, Kintavo was built for it.

12 frameworks. 50+ standards. Covered from day one — not configured after the fact.

KINTAVO ONE SPINE · 50+ STANDARDS
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21 CFR Part 11 → ISO 13485 → CLIA & CAP → AABB Standards → ISO 15189 → ISO 22000 →
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