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Consultancy services with deep roots

Quality & Compliance

Get input on strategy and operationalization from management consultants who have worked with the systems themselves and have deep regulatory and practical expertise

We have gained in-depth knowledge and expertise within GMP-regulated production thanks to numerous years of engineering experience from design, construction, validation and start-up of or changes to IT & Automation systems, production lines and facilities.

Furthermore, from the project management and management consulting services that we have provided to so many clients, we have developed a unique knowledge and expertise within GMP-regulated production.

It gives us the best possible basis for solid, operational advice within a lot of areas. Advice that ultimately creates results.

We help our clients create or adjust the strategic foundation, execute, implement and embed new processes, technology and culture within:

Quality Management Systems (QMS)

Enterprise Ressource Planning (ERP)

Architecture, technology and integration (e.g. hosting and cloud)

Project management (e.g. process optimization)

Our management consultants are able to work closely with the management team, as they were part of the client's management and can thus help to drive and realize management priorities.

We can also assist the client's QA organization, both in the form of sparring around strategy, the right quality level, choice of training system and peer review of documents, and we can also be part of the QA organization itself. However, we are reluctant to provide QA resources to - on behalf of the client - approve the documents that our specialists have prepared. Our integrity must never be questionable.

"I always try to build a bridge between different perspectives. The essence of this I transform into an action plan. Then, I start to execute the plan together with the stakeholders. This ensures success. "
Henrik Johanning
CEO & Senior Consultant

As a consequence of the changes in the requirements from the authorities and the optimization and changes in the production we often see the need for performing a GAP analysis to generate a prioritized list of the GxP-deficiencies in the company

We conduct GAP analysis and consultancy services to support you within:

The correct level of GxP (QMS and Audit readiness)
IT/OT and System Strategies
Procurement Processes, Service Level Agreements and Category Management setup

Portfolio and Project Management (e.g. Process optimization and governance)

Enterprise Resource Planning (ERP within QMS, Audit readiness, project control and sourcing activities)

Quality & Compliance contact

Henrik Johanning

CEO & Senior Consultant
  • IT & Automation / GAMP
  • Project Management
  • Management Consulting
  • GMP
  • Regulatory Affairs
  • Training

Simon Bagger

COO, Partner & Senior Consultant
  • IT & Automation / GAMP
  • Project Management
  • GMP
  • Computer System Validation
  • SAFe

Camilla Zenisek Ladegaard

Senior Consultant
  • QMS
  • ISO 13485
  • Audit
  • GMP
  • Validation
  • CAPA
  • Risk Management
  • FSCA
  • MDD & MDR
  • Project Management

Rune Koppel

Senior Consultant
  • Quality control
  • GMP
  • Deviations
  • CAPA
  • Change control