AI Governance · Risk · Compliance

AI Governance & Compliance Advisory for Regulated Organizations

Steer AI. Stay compliant.

Helping enterprises adopt AI safely through governance frameworks, risk management, compliance controls and audit-ready operating models.

Led by Fahad Syeed — 17+ years of enterprise technology, governance and digital-transformation leadership across global organisations including GSK, TCS and EMC.

Book a Discovery Call Get the AI Governance Checklist
Regulatory AI · Control Center Live efficiency & compliance Time to complete regulatory work manual vs. AI + governance · illustrative Manual With RegHelm less time Validated 21 CFR Part 11 Faster cycles less manual work Inspection audit-ready
17+ yrs enterprise & governance
Ex-GSK · TCS · EMC
AI governance & risk
Compliance & controls
Audit-ready operating models
Industries we serve
Pharma & Life Sciences Healthcare Technology & SaaS
Services

How I help you govern AI

Three focused engagements that take regulated organisations from AI uncertainty to a safe, compliant, audit‑ready operating model. Every engagement is scoped to you — pricing shared on a discovery call.

Start here

AI Governance Readiness Assessment

  • AI risk assessment
  • Governance gap analysis
  • Policy recommendations
  • Executive roadmap

Compliance Process Automation

  • Process review
  • Automation opportunities
  • AI-assisted compliance workflows

Risk & Control Assessment

  • Control effectiveness review
  • Compliance maturity assessment
  • Audit readiness recommendations
Productized engagement

AI Governance Readiness Assessment — in 2 weeks

A clear, fixed-scope engagement that takes you from "where do we even start?" to a board-ready plan you can act on. Deliverables:

  • Stakeholder interviews
  • Governance review
  • Risk assessment
  • Executive report
  • Implementation roadmap
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Inside each engagement

How the work unfolds

A clear, structured approach for each service. Click any diagram to view it full size.

AI Governance Readiness Assessment process: readiness assessment, AI risk assessment, governance gap analysis, policy recommendations and executive roadmap Compliance Process Automation: process review, automation opportunities and AI-assisted compliance workflows Risk and Control Assessment: control effectiveness review, compliance maturity assessment and audit readiness recommendations
Why now

Demand is real — the gap is governance

AI capability is outrunning organisational readiness. Regulators have legitimised AI; most teams still can't use it safely.

22%
of organisations have scaled AI (just 9% see real ROI)
79%
of enterprises face AI adoption challenges
1 in 5
have a mature governance model for agentic AI
~78%
of AI pilots stall before reaching production
Track record

What I've delivered

17+ years inside regulatory systems for a global top-10 pharmaceutical company. A few representative engagements — client details withheld for confidentiality.

Global submission automation

Automated packaging and delivery of regulatory submissions across CESP, the EMA Gateway and the FDA ESG — cutting manual effort and transmission errors, with an audit-ready trail.

Built & led a capability from scratch

Stood up a regulatory-systems and operations function from the ground up — building and leading a global, cross-functional team supporting EU & EEMEA to inspection-ready standards.

Automation & live dashboards

Replaced manual, spreadsheet-bound reporting with architected automation and live dashboards — cutting cycle times and enabling proactive, data-driven compliance.

Recognised internally for digital-transformation and innovation contributions. References available on request.

Why RegHelm

Why regulated teams choose RegHelm

Most advisors hand you a strategy deck. RegHelm gives you governance that passes inspection and automation your team actually uses — from someone who has done it inside a global pharmaceutical company for 17+ years.

Three disciplines in one

Regulatory affairs, AI, and enterprise systems architecture in a single advisor — the combination most teams would otherwise have to hire three people to cover.

Inspection-minded by default

Governance, validation and audit trails are designed in from the start — so what we build holds up under an FDA, EMA or auditor's scrutiny, not just in a demo.

We build, not just advise

You get working automation and controls, not slideware. A solution-architect approach that ships validated, scalable systems your team adopts and keeps using.

Senior, hands-on attention

You work directly with a 17+ year practitioner who has led global regulatory and transformation programmes — not a rotating bench of juniors.

Vendor-neutral by design

No product to sell. Solutions are designed around your existing stack and processes — so the recommendations you get are ones you can actually trust.

Fast, productized engagements

Clear scope, fixed deliverables and a 2-week AI Governance Readiness Assessment to start — momentum in weeks, not quarters.

Automation

Take the busywork out of regulatory ops

Most regulatory teams lose hours every week to manual packaging, tracking and reporting. I automate the repetitive work — so your people focus on judgment, not copy-paste. These are the automations companies ask for most.

Submission delivery automation

Automate packaging, validation and dispatch to CESP, the EMA Gateway and the FDA ESG — fewer errors, faster filings, full audit trail.

Compliance dashboards

Live dashboards for submission status, KPIs, commitments and due dates — real-time visibility for leadership, on whatever platform fits your stack.

Workflow & approval automation

Automate routing, approvals, reminders and handoffs — designed around your processes, not a single tool. No more chasing.

Tracking & alerts

Automated trackers and alerts for registrations, renewals, commitments and deadlines — so nothing slips.

System integration

Connect Veeva Vault / RIM, QMS, LIMS and spreadsheets so data flows automatically — no rekeying, no silos.

Document & report automation

Auto-generate reports and correspondence logs, manage metadata, and automate document assembly and bookmarking.

AI-powered ESG submission process via the EMA and FDA Gateway: smart preparation, one-click submission, validation, AI-augmented routing and faster decisions

Automate a manual process

How I work

A clear, inspection-minded path

A simple, proven sequence that takes you from "we want to use AI" to AI running in production — safely, and faster than teams expect.

STEP 01

Assess

Map your workflows and the highest-value AI use-cases, with a clear risk and governance view.

STEP 02

Govern

Put the policy, validation and human-in-the-loop controls in place so AI passes inspection.

STEP 03

Pilot

Run a tightly scoped, governed pilot that proves value with guardrails — not a science project.

STEP 04

Scale

Move from pilot to production, with monitoring and a lifecycle that keeps you compliant over time.

Built for compliance

Aligned to the frameworks that govern AI

Every engagement is designed to align with the AI governance, risk and compliance frameworks your regulators and auditors expect — so what we build holds up under scrutiny.

EU AI Act
NIST AI RMF
ISO/IEC 42001
FDA & EMA
21 CFR Part 11
GxP

Standards and frameworks RegHelm aligns work to — not certifications or endorsements. Names and marks belong to their respective owners.

About

Enterprise governance meets hands-on AI

A rare combination — and the reason RegHelm helps regulated organisations adopt AI in a way that survives scrutiny.

I've spent 17+ years at the intersection of governance, regulatory affairs and enterprise technology. Most recently I led EU and EEMEA enablement for GSK's global regulatory systems; earlier I held senior technology, quality and delivery roles at Dell Technologies, EMC and Tata Consultancy Services (TCS).

I've stood up governance and systems capabilities from the ground up, and architected the automation and controls that make compliance faster, more reliable and audit-ready.

As a senior leader and innovation/transformation lead, I've built and led global, cross-functional teams and turned business strategy into regulatory and digital change that actually sticks — driving adoption, not just delivering tools. I understand both the compliance detail and the business transformation around it.

That perspective sits on a deep technical foundation — earlier in my career, enterprise software quality and validation, storage and infrastructure systems, and large-scale IT service delivery for global technology companies. It's why I approach problems as a solution architect: designing validated, scalable systems that last, not one-off fixes.

Most AI consultants understand models but not GxP. Most regulatory experts don't architect systems or lead change. I do all three — which is why I can help you adopt AI in a way that survives an inspection and gets used.

Senior Leadership Business & Digital Transformation Change Management Regulatory Operations Veeva Vault / RIM AI Governance 21 CFR Part 11 Solution Architecture EU / EEMEA / FDA
Fahad Syeed
AI Governance & Compliance Advisor · Founder, RegHelm
Background: GSK · Dell Technologies · EMC · TCS
Work with me View LinkedIn
Regulatory Intelligence

Stay ahead of FDA, EMA & AI rule changes

A live hub of the latest updates from the FDA, EMA, MHRA and NIST — collected, organised by theme and interpreted for regulated teams, so you know what changed and what to do about it.

Open the intelligence hub →

Tools & downloads

Ready-to-use AI governance tools

Practical, editable templates and toolkits built from real regulated-industry engagements — download instantly and put them to work the same day.

★ Interactive — AI Governance Readiness Assessment

Not a spreadsheet — a real tool. Answer 24 questions and get an instant maturity score, a Red/Amber/Green dashboard and a full prioritised action plan in about 5 minutes — free while in preview.

Launch the tool →
Word · editable

AI Governance Policy Pack

A complete, adaptable AI governance policy and framework — aligned to the EU AI Act, NIST AI RMF and ISO/IEC 42001.

  • 13-section policy template, fully editable
  • Roles, responsibilities & risk-tier tables
  • Framework-mapping appendix
$79
Buy on Gumroad
Excel · auto-scoring

AI Readiness Assessment Toolkit

Score your AI governance maturity across eight domains and get an instant Red / Amber / Green dashboard.

  • 40-point scored assessment
  • Auto-calculating dashboard & chart
  • Maturity levels & leadership-ready view
$99
Buy on Gumroad
Excel · auto-scoring

AI Risk Register & Controls

Identify, rate and track AI risks with auto-scored inherent and residual risk, plus a built-in control library.

  • Pre-built register with worked examples
  • Automatic risk scoring & RAG status
  • 12-control library + summary view
$59
Buy on Gumroad
Word · 6 templates

Audit-Readiness Evidence Pack

Six fillable templates to assemble the evidence auditors and inspectors ask for.

  • AI inventory, validation record, oversight log
  • Vendor due-diligence questionnaire
  • Decision record + audit evidence checklist
$129
Buy on Gumroad

Complete AI Governance Toolkit

All four tools together — policy, readiness assessment, risk register and audit-readiness pack. Everything you need to stand up AI governance, at a bundle price.

$249Save $117
Get the bundle

Instant download after secure checkout via Gumroad. One-time purchase · licensed for use within your organisation.

Free resource

The AI Governance Checklist

A practical, audit-minded checklist for adopting AI in regulated organisations — covering strategy, data, validation, human-in-the-loop, documentation and governance. If you can't tick most boxes, that's where the risk hides.

Download the checklist
No cost. No spam.
Get in touch

Let's talk about where AI fits

Book a Google Meet, message me on WhatsApp, or email — I reply personally, usually within a day.

@ fahad@reghelm.com ☎ +91 97404 66633 Chat on WhatsApp in linkedin.com/in/fahad-syeed 📅 Book a Discovery Call (Google Meet)
Based in Bengaluru, India · working remotely with clients globally (EU, UK, US, Middle East).

Fastest ways to reach me

Pick whatever's easiest — they all come straight to me.

📅  Book a Discovery Call ✉  Email fahad@reghelm.com