GOVERNANCE · PROGRAMMESYNTHETIC DATARA LEAD · DRUG
Programme, People & Delivery
Discovery through global rollout, the people who decide and operate, and the risks carried forward.
PHASE 0
Discovery
Ten workshop hours in 2–4 hour blocks, kickoff in person at Thane, the rest remote.
Artefact readiness assessment
Dossier lifecycle mapped end to end
Indicative solution architecture
Roadmap with timeline and commercials
USD 10,000 fixed · invoiced 15 days after sign-off
PHASE 1
Foundation Build
One or two dossiers end to end: intake, OCR, master model, template rule engine, gap analysis.
Master dossier model and repository
CTD → ACTD rule engine
OCR, bookmarking, hyperlinking pipeline
Production releases every 2–3 weeks
Front-loaded phase · 40 / 30 / 30
PHASE 2
Market Enablement
Up to two pilot markets confirmed by Mega — Southeast Asia first.
Pilot market templates and checklists
Language versions with certification gate
Query round and variation tracking
MVP acceptance with RA operations
Phase fee at acceptance · timelines TBD
PHASE 3
Global Rollout
All products and markets, Azure-hosted and Good AI managed, two weeks hypercare after deployment.
Remaining markets and formats onboarded
Regulatory monitoring live per authority
IQ / OQ documentation
Hypercare then support
Separate SOW · no obligation beyond discovery
VS
Dr. Vikram Sathe
Business driver, Mega Life Sciences
Wants real automation rather than a digital photocopier — the system was built ten years ago and never truly used.
DECISION MAKER
RM
Rajiv Menon
GM Regulatory Affairs · single point of contact
Fifteen years at Mega, co-built the legacy system, runs prescription outsourcing from Mumbai with a team of 14.
OPERATIONAL LEAD
ND
Nita Deshpande
Director RA & QA
Released the original templates in 2016 and approves every revision before it can be used in a live project. Named SOW signatory.
TEMPLATE APPROVER
KR
Kiran
Chief Information Officer
Owns the AI and data agenda: the legacy platform is end-of-life, there is no lakehouse yet, and being AI-ready comes before any use case.
TECHNOLOGY GATE
Discovery Prerequisites
Validated before session one so the ten hours go to discussion, not orientation.
CDA executed with Mega Life Sciences ThailandPENDING
Shared drive with CTD, ACTD and final approved dossiersREQUESTED
Test instance of the 2015 system for the Good AI teamAGREED
Named attendees, roles and office locationsAGREED
Artefact completeness validated before session oneIN PROGRESS
Regulatory SME confirmed for the sessionsOPEN
Session Plan
Ten workshop hours in 2–4 hour blocks; kickoff in person at Thane, the rest remote.
S1Kickoff and lifecycle walkthroughDr. Sathe, Rajiv, RA leads · in person, Thane3 h
S2Master dossier structure and intake formatsRajiv, compilation managers2 h
S3Templates: ACTD, Peru and Ethiopia nationalRA market owners, Nita Deshpande2 h
S4Query rounds, variations, renewals, supplier loopRajiv, QA2 h
S5Findings playback and roadmapDr. Sathe, Nita, Kiran, Good AI1 h
Risks Carried Into Delivery
HIGH
Adoption, not capability
The 2015 system worked and was never adopted. UX-first design with sign-off at every step, so Mega owns the interface outcome.
HIGH
Incomplete artefacts before discovery
Validate the shared drive against the prerequisite checklist before session one, not during it.
MEDIUM
No written SOPs exist
Process lives only inside the legacy system and in people. Reconstruct it from screens, templates and interviews.
MEDIUM
Domain depth on the vendor side
Mega RA carries 20–25 years each. A regulatory SME is confirmed before the first client-facing session.
SYNTHETIC DATAAll data on this page is synthetic. Product names, brands, people, project numbers, suppliers, authorities, dates and figures were generated for demonstration and represent no real product, person, filing, supplier or company record. Structure and rules illustrate how the platform behaves, not any actual submission.