GMP and compliance

NNE helps customers achieve and maintain GMP compliance throughout the lifecycle of a product by delivering customised compliance services, from problem solving to compliance achievement.

  • Quality systems development and support
  • GMP strategy development
  • Quality support on optimisation, implementation and training
  • Audits and quality assurance services
  • Process validation services (QbD, DoE, PAT, QMR/QRA)
  • Root cause analysis and other CAPA support
  • Mock inspections/GAP analysis, and inspection readiness assessments
  • Remediation programmes
  • GMP compliance training

With our certified and pharmaceutically trained professionals, NNE offers you a seamless fulfilment of GMP. We have the expertise and international experience to handle the ever-more complex quality demands, through GMP-compliant design and solutions, quality documentation and validation in projects.

Good manufacturing practice is in our DNA

Ever since Danish Novo Nordisk and German Fresenius started building pharma facilities, we have provided specialist pharma engineering skills.

We were born and raised with the process and production understanding of a pharma company. This is the foundation of our cross-technical teams of engineers, architects, chemists and pharmacists when they design, construct, validate and start up facilities. But it also enables us to support manufacturing operations with services within optimisation, product and process development, pilot plants and laboratories.

Our combination of consulting and engineering services means that we are able to develop and implement seamless GMP solutions and services that are future-proof and operational. Having this in-depth GMP knowledge is what differentiates us from our competitors – we are pharma engineers, not just engineers.