COMPLIVISE connects pharmacovigilance, regulatory, labelling and quality — so one change is assessed, assigned, actioned and evidenced in one place.
A Spearhub Initiative · Technology delivery since 2019 · Hyderabad, India
COMPLIVISEIntelligenceEcosystemTrack record, platforms and standards
Regulated pharmaceutical systems built since 2019 — on qualified cloud infrastructure, against the standards inspectors actually audit.
Built to operate under
What teams tell us — and what COMPLIVISE does about it.
Regulatory change arrives faster than teams can assess it.
Impact assessment, CMC gap analysis and label actions in one place.
Signal work stalls across FAERS, VigiBase and internal data.
Multi-database extrapolation with case series and causality review, qualitative signal detection and assessment.
MICC , Literature screening, ICSR and aggregate live in separate tools.
Safety Information-to-ICSR as unified path with XML and aggregate support.
CCDS comparison shows differences but not consequences.
Comparison tied to market impact, CSI preparation and owners.
Manual, repetitive steps create delay and rework.
Configurable workflows that automate the routine, not the judgement.
Scattered documents leave audits without a traceable story.
Centralised evidence and end-to-end, inspection-ready audit trail.
COMPLIVISE turns those challenges into controlled, intelligent and compliant outcomes.
Every product follows the same five stages.
Literature, safety sources, studies, RWE, regulatory updates, labels and quality records.
Search, extraction, screening, comparison, classification and monitoring.
Patient-safety, product, regulatory, risk assessment, labelling and quality implications.
Case processing, label updates, submissions, CAPA and change control.
Sources, decisions, approvals, ownership, version history and completion records.
Pharmacovigilance, regulatory, labelling and quality. Not clinical development.
Each layer is a working product. Open one to see it end to end.
One platform
The six layers share products, markets, documents and actions — so a decision in one place is visible in the others.
Four functions, no re-keying, one unbroken evidence chain.
Regulatory Intelligence
Monitoring picks up a published safety communication and records the source, publication date and issuing authority.
REG-2026-0192 · published 11 Aug
Regulatory Intelligence
The substance class is matched to marketed products; a reviewer confirms relevance and records the rationale.
2 products in scope · reviewer confirmed
Signal Intelligence
Existing ICSRs and screened literature records carrying the same event term are retrieved and attached.
9 cases · 3 literature records linked
Label Intelligence
CCDS section 4.4 is compared against regional labels; two markets require wording changes, one is already aligned.
Section 4.4 · 3 markets assessed
Quality Intelligence
A CAPA and a change-control record are raised, linked back to the originating regulatory update.
CAPA-2026-118 · CC-2026-047
Across all layers
Each action has a named owner, a due date and a second reviewer where maker-checker is configured.
6 actions · 4 owners · 2 reviewers
Evidence
The source, assessments, decisions, approvals and closure records stay connected to the original change.
Complete chain retained
Illustrative product experience, based on a routine safety communication.
Four workflows as they run today, and the same workflows connected. Illustrative maps — no client names.
Reports arrive as email bodies, scanned forms, partner spreadsheets and literature records. Case creation depends on one associate reading each item and re-typing it into the safety database.
Before — how the work runs today
Mailbox
Mixed formats, no queue position
Manual triage
Read, judge validity, decide priority
Spreadsheet log
Parallel tracker outside the database
Email handoff
Medical review requested by message
Database entry
Fields re-keyed from the source
After — with COMPLIVISE in the workflow
Intake
Literature, mailboxes and partner files land in one queue
Assisted extraction
Fields proposed with source excerpts
Assessment
Validity, seriousness, duplicate evaluation
Assigned review
Named medical reviewer, due date
Structured handoff
ICSR XML export with retained provenance
Where it breaks down
What the system performs
Evidence retained
One shared platform: configuration replaces custom rebuilds, and the same controls apply everywhere.
An answer without its source is not usable. AI accelerates reading and classification; qualified professionals make the decisions that carry regulatory weight.
Evidence-grounded review — proposed extraction
Case SAF-2026-0841 · source: reporter narrative, page 2
Source passage
“The patient was admitted to hospital for three days following the second dose and was discharged in a stable condition.”
The highlighted passage is the only basis for the proposal on the right.
Proposed for review
Whichever the reviewer chooses is recorded with their identity, the original proposal and the timestamp.
Illustrative product experience. AI proposes; a qualified professional decides.
Technical controls, validation activities and regulatory requirements depend on the system's intended use, deployment configuration and the customer's operating procedures. COMPLIVISE works with customers to define and support the appropriate controls and documentation.
Take this with you
Twelve questions on intended use, traceability, human review and validation. Use it against any vendor — including us.
Nine questions, three minutes. Your result appears immediately — details only if you want the written brief.
Question 1 of 9
Information fragmentation
Not shipping today. Active development areas where a co-development partner shapes what is built first.
PSUR/PBRER preparation from source collection and reconciliation through drafting support and approval.
Requirement mapping and gap identification across CMC, stability, analytical and labelling content before filing.
You rarely need a platform rebuild. You need one workflow to work properly, then the next.
Deploy a COMPLIVISE product accelerator.
Adapt terminology, fields, workflows, roles, rules and reports.
Add organization-specific modules, analytics and integrations.
Launch selected solutions under the client's identity and operating model.
Co-develop a custom safety, regulatory, labelling or quality platform.
Solutions begin with the pharmaceutical workflow—not a generic AI capability.
Reusable platforms create faster implementations and stronger long-term foundations.
Choose pre-built products, configuration, white-labelling or custom development.
Strategy, design, engineering, integration, deployment and managed support from one team.
Company
“Pharmaceutical teams do not need more dashboards. They need the distance between knowing something and having acted on it to get shorter — without losing the record of how the decision was made.”
Founder’s position · COMPLIVISE, A Spearhub Initiative
COMPLIVISE is the pharmaceutical intelligence practice of Spearhub, a technology company delivering enterprise platforms, applied AI and workflow systems since 2019. The practice exists because pharmacovigilance, regulatory, labelling and quality teams share the same underlying problem, and almost never share a system.
2019
Spearhub technology-delivery journey begins
Product Engineering
Enterprise platforms, mobile products, cloud systems and automation
Applied AI
Intelligent search, document processing, workflow automation and agent-based systems
COMPLIVISE
Dedicated pharmaceutical intelligence practice
Describe the workflow that costs your team the most time. We will tell you honestly whether we fit.