REGULATED DIGITAL TRANSFORMATION

Build Digital Capabilities
That Last

Hands-on consulting for regulated industries. We build compliant digital infrastructure, transfer the capability to your teams, and leave your organisation more self-sufficient.

What we do

Digital Product Development· Pharma 4.0· Agentic Software Engineering· Automated Testing· Continous Validation, Integration & Deployment· Data Management· Computer System Validation (CSV)· Cloud Computing

Our Capabilities References

50+

Combined years of practitioner experience

Compliance frameworks we actively work with

Industries: pharma, manufacturing, aerospace

Office in Leiden

Why DCC?

Senior practitioners,
not junior staff

When you engage DCC, the consultant who scopes the work is the same person who delivers it. No handoffs to junior resources, no bait-and-switch. Our team has direct experience implementing IEC 62443 network segmentation, validating LIMS and QMS systems under 21 CFR Part 11, and managing IT roadmaps for GMP facilities — not as oversight, but hands-on.

We build systems that pass audits and transfer the capability to run them independently. After an engagement, your team owns the competency — not a dependency on external consultants.

Leiden, NL

Pharma · Manufacturing · Aerospace

What We Do

What we deliver

Six core capabilities, each grounded in hands-on delivery experience across GMP facilities, industrial control environments, and regulated manufacturing.

Regulated Application Development

Production-grade applications for GMP environments — from environmental monitoring dashboards to quality management workflows. Built on scalable architectures that satisfy both IT governance and validation requirements.

MendixAzureGAMP 5

Compliance Architecture

Designing compliance into digital infrastructure from the ground up. We map regulatory requirements to technical controls so your systems are audit-ready before the auditor arrives — not as an afterthought.

IEC 62443NIS221 CFR 11ISO 27001

OT/IT Security & Segmentation

Network segmentation for production environments using the Purdue Reference Model and IEC 62443 zones and conduits. Identity-based access control with Cisco ISE. Defence-in-depth for bioreactors, cleanrooms, and SCADA systems.

Purdue ModelCisco ISESCADA

Capability Transfer

Your team runs the systems after we leave. We embed with your people, co-develop solutions, and conduct structured knowledge transfer — so the transformation is owned internally, not dependent on consultants.

Co-creationTrainingChange Mgmt

IT Roadmapping for Regulated Sites

Technology roadmaps that account for validation timelines, GMP change control, and phased deployment in live production environments. From maturity assessment through execution planning.

RoadmappingAssessmentGxP

System Integration

Connecting EMS, BMS, LIMS, QMS, and ERP into a single digital platform. We handle data extraction, environmental monitoring integration, and quality management system connections for regulated manufacturing.

LIMSQMSEMS/BMSERP

Our Approach

How we deliver transformation

Cutting through the "noise" of large organizations to achieve successful results.

Assess & Scope

We start by understanding your regulatory landscape, existing systems, and organisational constraints. No generic frameworks — we map your specific compliance obligations to technical requirements before proposing anything.

Build & Validate

Our consultants work embedded in your teams, building solutions that meet both business needs and validation requirements. Every deliverable is designed to pass audit from day one — because retrofitting compliance is always more expensive.

Transfer & Exit

We document, train, and hand over. Your team should be able to maintain, extend, and govern the systems we built — without calling us. A successful engagement ends with DCC being unnecessary.

Industries

Regulated industries we serve

Deep domain knowledge in sectors where compliance, safety, and accuracy are non-negotiable.

Pharmaceutical & Biotech

GxP-compliant digital systems for cell & gene therapy manufacturers, CDMOs, and pharmaceutical companies.

GxP EU GMP Annex 1 21 CFR 11

Manufacturing & Energy

OT/IT security, network segmentation, and digital transformation for industrial control system environments.

IEC 62443 NIS2 SCADA

Aerospace

Digital product management and regulated application delivery for aerospace manufacturing and MRO operations.

GAMP 5 ISO 27001

The Team

The people who do the work

Every DCC consultant is a senior practitioner with direct experience in regulated environments. No account managers, no junior staffing — the team you meet is the team that delivers.

Kees Mensch

Partner

Jasper Donkers

Management Consultant

Michael Stremmelaar

Lead Developer

Abdullah Ameen

Developer & QA

Guido Verdu

Consultant

Nick Frietman

Junior DevOps Developer

Jasper Peeters

Junior UX/UI Designer

What Our Clients Say

“DCC does more than what you may expect from a consulting firm. They deliver a team effort and use their experience and expertise to make a success of the projects.”

Ruben van Dam

Programme Manager, Enexis

“DCC was highly instrumental in training colleagues in the Business Engineering way of working, shaping the delivery organization for the challenges ahead.”

Volker Boeing

VP Content & Process Management, Springer Nature

“DCC has formulated a complete roadmap for the entire IT infrastructure and relieves us on the sometimes unpredictable path of realization.”

Gerard van Loon

CFO, NecstGen

References