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.
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.
A clear, fixed-scope engagement that takes you from "where do we even start?" to a board-ready plan you can act on. Deliverables:
AI capability is outrunning organisational readiness. Regulators have legitimised AI; most teams still can't use it safely.
17+ years inside regulatory systems for a global top-10 pharmaceutical company. A few representative engagements — client details withheld for confidentiality.
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.
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.
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.
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.
Automate packaging, validation and dispatch to CESP, the EMA Gateway and the FDA ESG — fewer errors, faster filings, full audit trail.
Live dashboards for submission status, KPIs, commitments and due dates — real-time visibility for leadership, on whatever platform fits your stack.
Automate routing, approvals, reminders and handoffs — designed around your processes, not a single tool. No more chasing.
Automated trackers and alerts for registrations, renewals, commitments and deadlines — so nothing slips.
Connect Veeva Vault / RIM, QMS, LIMS and spreadsheets so data flows automatically — no rekeying, no silos.
Auto-generate reports and correspondence logs, manage metadata, and automate document assembly and bookmarking.
A simple, proven sequence that takes you from "we want to use AI" to AI running in production — safely, and faster than teams expect.
Map your workflows and the highest-value AI use-cases, with a clear risk and governance view.
Put the policy, validation and human-in-the-loop controls in place so AI passes inspection.
Run a tightly scoped, governed pilot that proves value with guardrails — not a science project.
Move from pilot to production, with monitoring and a lifecycle that keeps you compliant over time.
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.
Standards and frameworks RegHelm aligns work to — not certifications or endorsements. Names and marks belong to their respective owners.
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.
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.
Book a Google Meet, message me on WhatsApp, or email — I reply personally, usually within a day.
Pick whatever's easiest — they all come straight to me.
📅 Book a Discovery Call Chat on WhatsApp ✉ Email fahad@reghelm.com