generated: '2026-08-02'
method: searched
source: >-
  vedantabio.com (mission, pipeline, partnerships, expanded-access pages), PureTech Health
  and BARDA/CARB-X announcements, and the live probes recorded in
  well-known/vedanta-biosciences-well-known.yml (2026-08-02)
scope: >-
  Vedanta Biosciences publishes no API, so there are no API or cross-cutting technical
  standards to assert. What the company is actually measured against is the US and
  international drug-development regulatory pathway for a Live Biotherapeutic Product.
  That pathway is recorded here as the applicable regime, with status stated honestly as
  in-progress rather than achieved. The API/protocol standards block below is recorded as
  applicable:false rather than a bare false, so this file is never mistaken for a
  compliance posture the company does not claim.
regulatory_regime:
- id: fda-ind-bla-live-biotherapeutic-product
  name: >-
    US FDA CBER pathway for Live Biotherapeutic Products (IND -> registrational trial ->
    Biologics License Application)
  conforms: false
  status: in-progress
  evidence: >-
    VE303 is in the global Phase 3 RESTORATiVE303 registrational study for prevention of
    recurrent Clostridioides difficile infection, following a Phase 2 study reported as
    showing a greater than 80% reduction in the odds of CDI recurrence versus placebo. No
    FDA licensure/approval for any Vedanta product has been announced.
  note: >-
    Recorded as conforms:false because licensure has not been granted, not because a check
    was failed. Re-probe on the next pass.
- id: clinicaltrials-gov-registration
  name: US FDAAA 801 / ICMJE public clinical-trial registration
  conforms: true
  evidence: >-
    Vedanta publicly identifies and describes its registrational study by name
    (RESTORATiVE303) and maintains a patient-facing trial page at
    https://www.vedantabio.com/commitment-to-patients/restorative303/
- id: expanded-access-policy-21st-century-cures
  name: >-
    US 21st Century Cures Act section 3032 public expanded-access (compassionate use)
    policy requirement for investigational drugs
  conforms: true
  evidence: >-
    A public expanded access policy is published at
    https://www.vedantabio.com/commitment-to-patients/expanded-access-policy/
- id: cgmp-live-organism-manufacturing
  name: cGMP manufacture of live biotherapeutic drug product from clonal cell banks
  conforms: true
  status: claimed
  evidence: >-
    The company describes in-house technical expertise in the manufacture of live
    organisms and production from pure clonal cell banks
    (https://www.vedantabio.com/our-science/manufacturing/). This is a company claim, not
    an independently verified certificate.
- id: barda-carbx-funded-development
  name: US BARDA and CARB-X non-dilutive development awards
  conforms: true
  evidence: >-
    https://www.vedantabio.com/who-we-are/partnerships/ documents BARDA reimbursement of
    up to $114.2M for VE303 subject to milestones, and CARB-X research grants supporting
    VE303 and VE707.
api_standards:
- id: openapi
  conforms: false
  applicable: false
  evidence: no public API contract published (see well-known/vedanta-biosciences-well-known.yml)
- id: asyncapi
  conforms: false
  applicable: false
- id: graphql
  conforms: false
  applicable: false
- id: oauth2
  conforms: false
  applicable: false
- id: openid-connect
  conforms: false
  applicable: false
- id: rfc9457-problem-details
  conforms: false
  applicable: false
- id: mcp
  conforms: false
  applicable: false
- id: a2a
  conforms: false
  applicable: false
  evidence: >-
    /.well-known/agent-card.json and /.well-known/agent.json both 404 on vedantabio.com
    and www.vedantabio.com
- id: rfc9116-security-txt
  conforms: false
  applicable: true
  evidence: /.well-known/security.txt returns 404 on both hosts
information_security_compliance:
  found: false
  note: >-
    No trust center, SOC 2, ISO 27001, HITRUST or equivalent information-security
    certification page was found by probe-security-programs.py (vdp=none trust=none) or by
    search; trust.vedantabio.com and security.vedantabio.com do not resolve. No `Compliance`
    pointer is wired in apis.yml, and the FDA/cGMP regime above is a drug-development
    regime, not a published infosec compliance program, so it does not earn one either.
domain_security_observed:
  source: security/vedanta-biosciences-domain-security.yml
  summary: >-
    www.vedantabio.com serves TLS 1.3; HSTS is NOT enabled. The vedantabio.com domain has
    DNSSEC, SPF and DMARC present, with DMARC policy p=quarantine and no CAA record
    published.