Why is it important?

The pharmaceutical industry has always been particularly challenging given regulatory requirements /GxP that make operational improvements and capability building challenging. The vision is to adapt 'Lean (Digital) GxP moving towards “continuous (transparent) compliance"

Our experience

We have over 15-years of experience developing GxP compliant Operational Excellence in global pharmaceutical companies. Our collaboration with NSF (National Samitation Foundation) an International provider services incl Remediation, Qualification of QPs, Quality Systems/Compliance Audits to the pharmaceutical, biotech and devices industries, enable our unique 'Lean GxP' perspective and approach


We have consistenly managed a positive ROI on our Transformation (12+ months) projects, whilst embedding the processes and skills to ensure Sustainability and continued improvements.
We base our joint targets on your success criteria

+ 0 %
production capacity
- 45 %
huron error (CAPA effectiveness)
+ 0 %
OEE improvement
0 +
new ideas per person/year
0 %
safety risks
+ 0 %
employee development / engagement into the CI process

Main workstreams

Based on a Diagnostic of the business challenges and Current State of operations, we develop a tailored Future State with detailed Implementation Plan, measurable objectives (KPIs), typically including some or all of the below Workstreams

Strategy and Production system design

Developing a vision, strategy and measurable plan (Hoshin Kanri) that can be deployed across the organization. Designing and tailoring industry/ company specific Production or Operating Systems, covering all direct and indirect functions.

Supplier management and development

Complete span of support of suppliers, from selection, through to strategic development to 'partnerships'. Also Supplier Interventions, if impacting (QCD) production or Cost Reduction, optimizing process and costings, leveraging continuous improvement and other lean tools.

Lean Organization

Building an effective organisational span of control, roles and responsibilities and processes, as a foundation for a culture of continuous improvement and problem solving that is maintained at all levels.

Performance/Shopfloor Management

Visual management and cascade of key performance indicators (KPIs) and SMART Targets. Shopfloor Management; effectively prioritizing issues, early intervention (containment), effective problem solving of recuring issues and process confirmation to prevent reaccurance.

Focused Improvement projects

Applying methods and tools in a step change improvement in performance in given area or process, to show impact and/or have initial quick-wins.

Lean Digitalization

Digital diagnostics of IT/OT, identify digital waste and potential digital value added Create Future and Ideal States with digital VSM, Systems architecture maps, Entity Relationship Diagrams to mesh/mock up simulations to tailored plan.

Leadership Development

Coaching and capability development based Standard work for leaders including process confirmation, go look see, planning and escalation, coaching and problem solving, creating high performing teams.

Change Agent Development

Set up training and development of a critical mass of Internal specialists, experts and coaches to replace external support and drive and sustain implementation of company Operating/lean System.

New Product Introduction (NPI)

Development of processes and capabilities to launch products or services on quality, cost and delivery targets and building in lessons learnt, built into next iteration (Keshikomi).

Case Studies

Check out case studies from our pharmaceutical clients!

Novo Nordisk

Novo Nordisk is a leading global healthcare company who manufactures and markets pharmaceutical products and services specifically diabetes care medications and devices.

Farmak Operations

JSC “Farmak” is the leader of the Ukrainian pharmaceutical market and the largest exporter of medicinal products since 2010.

Farmak Quality

JSC “Farmak” is the leader of the Ukrainian pharmaceutical market and the largest exporter of medicinal products since 2010.