AegisLife Sciences
View
Case team · 10 named owners · view as any role
A
Akira Tanaka
RA Specialist · L1
2
P
Priya Nair
Clinical Affairs Lead
H
Dr. Hiroshi Sato
CMO · Medical Affairs
L
Dr. Lin Wei
Regulatory Lead
1
M
Marcus Yang
HEOR / Market Access Lead
D
Dev Krishnan
MLR Chair · Med/Legal/Reg
M
Mei Lin
Country GM · APAC Commercial
T
Tomás Ribeiro
QA · PMS Lead
3
S
Sarah Chen
CRO · Filing authority
A
Anika Reddy
VP Quality · Cross-cutting
Launch in flight · viewing as Sarah Chen (CRO)AGENT-READABLE
The launch is moving through 8 stages.
3 checkpoints wait on you.
Submission pack · in progress
Full submission pack
847 pages live · accumulating
Process · 8 stages across 3 phases · click any stage for details
P1Pre-launch · build the dossierD1 → D90 · 4 stages
P2Authority · file and defendD90 → D210 · 2 stages
P3Market · launch and watchD210 → 10y · 2 stages
01 · STRAT
MERIDIAN
Regulatory Strategy
8d · sealedAkira
no access
02 · EVID
VECTOR
Clinical Evidence
6w · sealedPriya
no access
03 · HEOR
ATLAS
Health Economics
d12 · liveMarcus
no access
04 · SUBM
HERMES
Submission
3w budgetAkira
no access
05 · REVW
SENTINEL
Authority Review
120d windowSarah
no access
06 · MLR
THEMIS
MLR Review
post-filingDev
no access
07 · ACCS
ATLAS
Market Access
Q4 26Mei
no access
08 · PMS
ORACLE
Post-Market
10-yr cont.Tomás
no access
Your next action
HEOR · AWAITING YOUR APPROVAL
ATLAS has surfaced the comparator choice. Your call.
Marcus Yang (Market Access Lead) has flagged this for CRO sign-off given downstream MEA implications. Two viable comparators: Reveal LINQ predicate ($18,200/QALY) vs lifetime model ($24,800/QALY) across all 7 APAC jurisdictions. Auto-escalates in 48h.
Stage details · ACTIVE · ESCALATED
03 · HEOR
Health Economics & Outcomes Research
ATLAS · economics agent
Vidura counseled on dharma and right allocation. This agent builds the economic case so humans can decide what is worth what.
Builds cost-effectiveness case across 7 APAC jurisdictions. Locks model against payer comparators, runs 78-scenario sensitivity scan, surfaces consequential choices.
Systems checked
PMDA C2 scheduleKFDA New HTAHSA relianceReveal LINQ corpusISPOR refs
OwnerM Marcus Yang · HEOR LeadEscalates toS Sarah Chen · CRO
Outcome: Model v2.1 locked. 47 of 78 scans complete. Comparator gate open — bands $18,200 vs $24,800 / QALY. Awaiting CRO sign-off.
Your pending checkpoints
1.Sign-off HEOR comparator · ATLAS paused at scenario 47/78 · Marcus escalated
~48 h
2.Approve submission filing · HERMES stages dossier for PMDA + 6 jurisdictions
~5 d
3.Launch-price seal · ATLAS reference-pricing output · Mei + Marcus review
~6 w
Workbench · governance-core surfaces · receipts, examiner bundles & policy registry
Receipt chain
Receipts
… receipts · SHA-256 anchored →
Examiner bundle
Examiner bundle
7 jurisdictions · auto-assembled →
Policy studio
Policy studio
… policies · … active →
Signed in as Sarah Chen · CRO · Filing authorityPermissions: All stages · Filing authority
DEMO MODE · CLICK ANY ROLE TO COMPARE VIEWS
© AEGIS · LIFESCIENCES.WITHAEGIS.AI · V1 · SANDBOX TENANT · AGENT-READABLE SURFACES
Governance trace · MEDTRONIC-ICM-001
Receipt chain · SHA-256 anchored
Strategy sealed
091d…4f8a
SAP locked v3
f12b…77e0
DSMB 04 cleared
d45a…c901
Evidence sealed
3e7c…8b29
HEOR model v2.1
building…
Human sign-offs to date
Akira · Strategy approval
12 Mar · ✓
Priya · DSMB packet 04
28 Apr · ✓
Lin Wei · SAP statistical sign-off
22 Apr · ✓
Priya · Evidence seal
02 May · ✓
Framework parity
21 CFR Part 11EU MDR Annex XIVMDCG 2020-7PMDAHSANMPATGA
Submission pack · table of contents · 847 pages · accumulating
SECTION 1 · CORE DOSSIER (CER + IFU + Risk file)
  CER v17                                312 pages   sealed 02 May
  IFU · EN + JA executable               18 pages    sealed 12 Apr
  Risk file v4 · ISO 14971               42 pages    sealed 08 Apr
  Value-claims pack                      24 pages    sealed 16 Apr
                                         ─────
                                         396 pages   ◯ sealed

SECTION 2 · CLINICAL EVIDENCE (per stage 02)
  SAP v3                                  28 pages    locked 22 Apr
  DSMB packets 01-04                      72 pages    locked
  Patient-level data export (SDTM)        —           linked
  Investigator Brochure v8                34 pages    sealed
                                          ─────
                                          134 pages   ◯ sealed

SECTION 3 · HEALTH ECONOMICS (per stage 03)
  ICER model v2.1                          42 pages   sealed 17 May
  78-scenario sensitivity scan             18 pages   building (47/78)
  Per-jurisdiction value cases              91 pages   sealed
  ISPOR reference set                        14 pages   linked
                                          ─────
                                          165 pages   ◐ accumulating

SECTION 4 · JURISDICTIONAL ANNEXES
  Annex 84-1 PMDA                          84 pages    sealed
  Annex 62-1 HSA                           62 pages    sealed
  Annex 58-1 KFDA                          58 pages    sealed
  Annex 54-1 TFDA                          54 pages    sealed
  Annex 22-1 HK                            22 pages    sealed
                                          ─────
                                          280 pages   ◯ sealed

SECTION 5 · POST-MARKET PLAN
  PMCF protocol v3                         16 pages    sealed 28 Mar
  3-yr PSUR template                        22 pages    sealed
  FSCA escalation matrix                    8 pages     sealed
                                          ─────
                                          46 pages    ◯ sealed

SECTION 6 · GOVERNANCE & RECEIPTS
  Receipt chain · all stages              —           SHA-256 anchored
  Agent reasoning traces                  —           per-decision
  Policy enforcement log                  —           POL-AGENT-OBSERVABILITY-V1
                                          ─────
                                          — pages     ◯ continuous

TOTAL                                   847 pages    ◐ accumulating
LAST SEAL                               17 May 17:11 UTC
DOWNLOAD[PDF][DocX][JSON manifest]
Audit log · MEDTRONIC-ICM-001 · all actions
Recent actions (last 24h)
Sarah Chen · Korea walk sealed (Scenario C) · 07 ACCS
8e2c…6f31
Sarah Chen · PMDA dossier filed · 04 SUBM
7f3b…91d4
M. Yang · VP Finance ack on walk · 07 ACCS
7d4a…9a13
ATLAS · Korea walk recommendation surfaced
6c39…8819
Sarah Chen · RFI #14 narrowing accepted · 05 REVW
091d…4f8a
ORACLE · 4.2σ Sydney battery signal (auto) · 08 PMS
auto…02a4
Dev Krishnan · MLR hard-block sustained · 06 MLR
c41a…77b8
Dr. Hiroshi Sato · INC-02-001 medical judgment · 02 EVID
a91c…3018
Stage seal timestamps
STAGE 01 STRAT SEALED 12 Mar A. Tanaka + S. Chen
✓
STAGE 02 EVID SEALED 02 May Priya Nair
✓
STAGE 03 HEOR SEALED 17 May M. Yang + S. Chen
✓
STAGE 04 SUBM ACTIVE 1 of 7 dossiers filed
◐
STAGE 05 REVW ACTIVE 1 of 240 RFIs sealed
◐
STAGE 06 MLR ACTIVE 1 of 208 verdicts in flight
◐
STAGE 07 ACCS ACTIVE 2 of 7 markets live · 1 walked
◐
STAGE 08 PMS ACTIVE 312/455 PMCF · 1 FSCA pending
◐
Human sign-offs
Akira Tanaka · Strategy approval
12 Mar · ✓
Priya Nair · DSMB packet 04
28 Apr · ✓
Lin Wei · SAP statistical sign-off
22 Apr · ✓
Priya Nair · Evidence seal
02 May · ✓
Marcus Yang · HEOR comparator
17 May · ✓
Sarah Chen · RFI #14 accept
17 May · ✓
Sarah Chen · PMDA file
17 May · ✓
Sarah Chen · Korea walk seal
17 May · ✓
Framework parity
21 CFR Part 11EU MDR Annex XIVMDCG 2020-7PMDAHSANMPATGA
Agents · MEDTRONIC-ICM-001 · 8 active
⬢ MERIDIAN · regulatory strategy
Stage 01 · sealed 12 Mar · 7 substages complete
Last action: handoff packet sealed → VECTOR
Model: claude-sonnet-4-6 · Prompt: POL-PROMPT-MERIDIAN-V3
⬢ VECTOR · clinical evidence
Stage 02 · sealed 02 May · CER v17 locked · 1 inc escalated
Last action: handoff packet sealed → ATLAS
Model: claude-sonnet-4-6 · Prompt: POL-PROMPT-VECTOR-V2
⬢ ATLAS · health economics
Stage 03 · live · scenario 47/78 · awaiting CRO sign-off
Last action: comparator gate opened (78 scans)
Model: claude-opus-4-7 · Prompt: POL-PROMPT-ATLAS-V1
⬢ HERMES · dossier assembly
Stage 04 · live · 1 of 7 dossiers filed (PMDA)
Last action: PMDA dossier sealed → SENTINEL
Model: claude-sonnet-4-6 · Prompt: POL-PROMPT-HERMES-V2
⬢ SENTINEL · authority Q&A response
Stage 05 · live · 1 of 240 RFIs sealed
Last action: PMDA RFI #14 response sealed
Model: claude-opus-4-7 · Prompt: POL-PROMPT-YUDHI-V2
⬢ THEMIS · MLR review
Stage 06 · continuous · 3 blocked · 41 in review
Last action: Korean asset hard-block sustained
Model: claude-sonnet-4-6 · Prompt: POL-PROMPT-THEMIS-V1
⬢ ATLAS · market access
Stage 07 · live · 2 markets live · 1 walked
Last action: Korea walk recommendation sealed
Model: claude-opus-4-7 · Prompt: POL-PROMPT-ATLAS-V2
⬢ ORACLE · post-market surveillance
Stage 08 · continuous · 312/455 cohort · 1 FSCA pending
Last action: 4.2σ Sydney battery signal escalated
Model: claude-sonnet-4-6 · Prompt: POL-PROMPT-ORACLE-V3
Coming soon

This surface ships in the next demo cut.

For the LINQ-NEXT walkthrough, the agent's reasoning trace and the sealed receipts are the proof — every action you've seen so far is governance-traceable.

Ask Ujjwal what you'd like to see next.