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Arcwork: Investor Overview

Building the compliance operations platform for every regulated industry. Started as artwork approval. Expanding into the full regulated product lifecycle.

Executive Summary

Company: Arcwork (India, pre-incorporation)

Stage: Private Beta — MVP shipped and live. Onboarding pilot customers across pharma, cosmetics, nutraceuticals, and FMCG.

The entry point: Artwork approval. Every regulated product — a drug, a supplement, a cosmetic — ships with a label. That label must be reviewed by QA, Regulatory, Marketing, and Legal before print. Today, this happens through email threads, WhatsApp, and spreadsheets. It takes 2–3 weeks. Mistakes cause recalls. There is no audit trail.

The bigger opportunity: Artwork approval is the surface problem. The underlying system failure is that regulated industries have no modern, integrated platform for document control, change management, formulation compliance, and approval workflows. Arcwork starts with artwork and expands into the full GxP compliance stack — the layer that sits between formulation and market.

Business Model: Recurring SaaS (per-user/per-month, India-first pricing). Expansion to global markets in subsequent phases. Enterprise tier targets mid-to-large manufacturers managing multiple SKUs across regulatory jurisdictions.

Platform Vision

Arcwork is not an artwork tool. It is a Regulated Product Lifecycle Management (PLM) platform — the compliance operations layer between formulation and market. Artwork approval is the beachhead. The platform is already architected for what comes next.

Document Control

Version-controlled regulated documents (labels, SOPs, dossiers) with full lifecycle: draft → review → approval → archive. Immutable history. Change-linked to BOM and formulation data.

Change Control

Formal change request system across documents, BOMs, template versions, and regulatory schedules. Every change triggers a configurable approval workflow with signoff requirements.

Formulation Intelligence

BOM management linked to global ingredient and regulatory schedule databases. Tracks ingredient schedule classifications, historical changes, and cross-industry validity — automating what compliance teams manually verify today.

Process Orchestration

Enterprise-grade workflow engine with parallel gateways, decision nodes, SLA enforcement, and role-based escalation. Any multi-step regulated process — not just artwork — can run through Arcwork.

Compliance Automation

AI-powered validation against FSSAI, FDA, EMA, and other regulatory frameworks. Configurable rule sets per document type and industry. Copy accuracy checks against approved master copy.

21 CFR Part 11 Layer

Cryptographic electronic signatures with non-repudiation, record snapshot hashing, and IP capture. Immutable audit logs on every entity. Multi-tenant isolation. Built to meet the evidentiary standards regulators demand.

Product

MVP (Live Now)

  • check Canvas Annotation & Review: Point, area, line, highlight, issue, and suggestion annotations directly on artwork. Fully resolved/unresolved lifecycle. Every annotation audit-logged.
  • check Workflow Engine with SLA: Custom approval chains (QA → Regulatory → Marketing); configurable signoff modes (ALL / ANY / COUNT); SLA hours per state with WARN / ESCALATE / BLOCK breach actions; full transition history.
  • check Process Orchestration Engine: BPM-style process definitions with sequential, conditional, and parallel flows; parallel gateways and merge nodes; multi-document process coordination.
  • check Change Control System: Formal change requests on documents, BOMs, template versions, and regulatory schedules — with workflow-governed approval chains and complete history.
  • check BOM & Formulation Management: Ingredient lists linked to global ingredient and regulatory schedule databases; ingredient group management; schedule history and cross-industry validity tracking.
  • check Compliance Engine: 21 FSSAI-aligned rules covering pharma, nutraceutical, and cosmetic categories. AI evaluates text-verifiable rules; visual rules flagged for human sign-off. Deterministic compliance score out of 100.
  • check Copy Accuracy Check: Compare artwork copy against approved master manuscript. Detects CASE, CONTENT, and MISSING deviations with confidence scoring.
  • check Label Element Check: Configurable rule sets per document type. Detects PRESENT, PARTIAL, ABSENT for each required label element.
  • check Version Diff: AI-powered structured comparison between artwork versions with confidence scoring and regulatory element extraction.
  • check Approval Report Generation: PDF reports capturing full document history, compliance scores, annotations, copy accuracy, and e-signatures — submission-ready.
  • check Cryptographic E-Signatures: 21 CFR Part 11-style electronic signatures with record snapshot hashing, IP capture, printed name, and meaning field. Linked to workflow signoffs and state transitions.
  • check External Reviewer Access: Invite external stakeholders (agencies, co-manufacturers) via tokenized access to specific documents — without granting system-wide access.
  • check RBAC + Audit Trail: Role-based access control at the workflow state level. Immutable audit log on every entity. Multi-tenant with schema-per-org isolation.

Planned

  • schedule Headless API for ERP, PLM, and supply chain integrations
  • schedule Webhook automation and third-party connectors
  • schedule Custom compliance rules engine (per-industry, per-market)
  • schedule Expanded global regulatory coverage (EU, US FDA, ASEAN)

Founder & Team

Poornendu Shukla
Software Engineer, Salesforce
8+ years enterprise SaaS. Built compliance and workflow systems at scale. Designed and shipped this platform solo.
Current Status
Solo founder. Full-time on Arcwork.

Funding Status

Current:
Bootstrapped. MVP designed and shipped by the founder.
Next Round:
Seed funding after establishing initial paying customers. Focus on team expansion, compliance certifications, and deeper regulatory coverage.

Why Now

  • trending_up
    India's regulated FMCG and pharma market is digitalizing fast — but compliance tooling remains a decade behind
  • smart_toy
    AI is now capable of reading artwork and evaluating regulatory compliance — something impossible to build affordably two years ago
  • business_center
    Incumbent platforms (Veeva, MasterControl) price out mid-market manufacturers — a massive underserved segment in India and Southeast Asia
  • lock
    Regulatory data (ingredient schedules, BOM history, signed approvals) creates high switching costs and deep customer retention

Competitive Moat

  • database
    Regulatory data layer: Global ingredient + schedule database linked to customer BOM — hard to replicate without domain depth
  • hub
    Unified platform: Workflow + BOM + compliance + e-signatures + change control in one system, not a stack of integrations
  • price_check
    India-right pricing: Modern SaaS at a price mid-market Indian manufacturers can actually buy — no enterprise sales cycle required

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