The One Major Problem the Pharma Industry Faces — and How REDE Consulting Is Solving It

The pharmaceutical industry operates in one of the most complex, highly regulated environments in the world. Every breakthrough, every product, every operational decision must pass through layers of compliance, quality, risk controls, and global regulatory oversight.

Yet despite all the investment in systems and processes, most pharma organizations face the same underlying problem:

Fragmented, manual, and inconsistent Risk & Compliance operations.

From GxP controls to vendor risk management, from global audits to ITGC testing — the challenge is the same everywhere:

• Too many systems

• Too many spreadsheets

• Too many manual reviews

• Too much time lost in evidence collection, approvals, and documentation

• Too many risks identified late, instead of predicted early

This fragmentation slows down teams, increases compliance costs, and leaves organizations exposed during audits and regulatory inspections.

And this is exactly the problem REDE Consulting has set out to solve.

REDE Consulting: A Brief Story of Expertise and Purpose

REDE started with a simple belief:

Risk & Compliance should enable pharma innovation — not slow it down.

Founded by domain experts who have spent years inside regulated industries, REDE saw firsthand the frustration experienced by compliance, IT, quality, and risk teams. They watched highly skilled professionals spending hours gathering evidence, responding to findings, or rebuilding documentation — instead of focusing on real risk insights.

So REDE built a different kind of consulting model — one that combines:

• Deep GRC, QMS, and cybersecurity domain knowledge

• Strong platform expertise across ServiceNow, Archer, MetricStream, AWS, and custom AI tooling

• A forward-thinking approach to automation, standardization, and AI-driven risk operations

Today, REDE Consulting is trusted by global pharma, biotech, and life sciences organizations to redesign their entire risk and compliance backbone.

The Problem REDE Solves: Bringing Order to Pharma’s Risk & Compliance Chaos

Pharma companies deal with enormous regulatory requirements:FDA, EMA, MHRA, Health Canada, WHO, ICH, GxP, 21 CFR Part 11, Annex 11 — the list is endless.

But the biggest bottleneck is not the regulations themselves.It’s the operational complexity of managing them.

REDE focuses on solving this in three core ways:

1. Turning Manual Controls Into Automated, Predictive Workflows

Most pharma organizations still rely heavily on:

• Manual ITGC testing

• Repetitive evidence collection

• Siloed GxP validation activities

• Audit readiness work done just before inspections

REDE deploys automation and AI to eliminate this reactive approach and replace it with:

✔ Continuous control monitoring✔ Automated evidence gathering✔ AI-driven validations and reconciliations✔ Predictive alerts long before risks become issues

This alone saves teams hundreds of hours every year.

2. Unifying Risk, Compliance, Quality, and IT Under One Connected Ecosystem

Pharma commonly struggles with risk and compliance data living in:

• LIMS

• QMS systems

• ERP

• Spreadsheets

• Legacy GRC tools

• Clinical systems

• Vendor portals

• Email chains

REDE builds connected risk ecosystems that unify all these silos, enabling:

✔ A single source of truth✔ Cross-functional visibility✔ Global standardization✔ Faster audits and smoother inspections✔ Consistent evidence for every regulator

3. Strengthening Vendor & Third-Party Risk in a Highly Outsourced Industry

Pharma relies heavily on:

• CROs

• CMOs

• API suppliers

• Technology vendors

• Cloud providers

• Laboratory partners

A weak vendor risk program becomes a regulatory liability.

REDE has become a leader in transforming Third-Party Risk Management by:

✔ Automating due diligence workflows✔ Using AI to analyze questionnaires and generate risk reports✔ Improving contract compliance✔ Enhancing fourth-party and supply-chain risk visibility✔ Ensuring faster onboarding with stronger resilience controls

Global pharma clients now use REDE frameworks to meet DORA, GxP, ISO, and data protection requirements efficiently.

How REDE Is Helping Global Pharma Companies Succeed

Across the world, REDE is enabling pharmaceutical firms to:

• Reduce audit and inspection readiness time by 40–60%

• Cut manual compliance tasks by 50–70%

• Shorten vendor onboarding cycles by 30%

• Improve ITGC test accuracy and traceability

• Standardize global processes across regions and business units

• Build modern GRC programs aligned to future regulatory expectations

In every engagement, REDE’s mission remains the same:

To make risk and compliance faster, smarter, predictable, and significantly more efficient — without compromising regulatory integrity.

The Future of Pharma Depends on Strong, Intelligent Compliance

As regulations evolve and digital transformation accelerates, pharma companies cannot rely on outdated, manual, disconnected risk processes.

The future belongs to organizations that can transform their compliance operations into:

• Intelligent

• Automated

• Predictive

• Unified

• Audit-ready at all times

And that is exactly where REDE Consulting is leading the way.

We design, implement and operate governance, risk and compliance programs on ServiceNow, deliver measurable cloud cost savings through FinOps, and build secure Databricks data platforms for high‑impact AI. We help CXOs turn compliance, cost and data into strategic advantage.

Whether it’s GxP, FDA, EMA, SOX, HIPAA, ISO, NIST, HITRUST, or a combination—our experts help you quickly identify what fits your business, your risks, and your regulatory obligations. 

Get a FREE, no-obligation consultation and clarity you can act on.

(a) Contact us at - info@rede-consulting.com (b) Website - www.REDE-Consulting.com