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Consulting Services

Your trusted partner in building sustainable quality systems that meet global quality standards and regulatory requirements.

Our Approach

A trusted partner

Your trusted partner in building sustainable quality systems that meet global quality standards and regulatory requirements.

Consulting Lines

Four core areas of expertise

EU GMP Consulting

Setting up quality systems in line with EudraLex Vol.4 and its Annexes, gap assessments and audit readiness.

  • Inspection preparation and audit readiness programmes
  • Gap assessment and action plan development
  • Setting up and managing CAPA processes
  • Cleanroom projects and Lean shop-floor management
  • Facility design and revision consulting
  • Contamination Control Strategy (CCS)
  • Annex 1 compliance

EXCiPACT GMP Consulting

GMP & GDP infrastructure for excipient manufacturers, risk-based quality systems and EXCiPACT audit preparation.

  • Aligning EXCiPACT GMP with ISO 9001
  • Setting up a risk-based quality system
  • Supplier qualification and audit systems
  • APQR (Annual Product Quality Review)
  • Distribution and storage systems under GDP
  • EXCiPACT audit preparation and mock audits

GxP Quality Systems Consulting

An integrated quality system approach covering cGMP, GLP, GDP and GCP. Industry-specific solutions.

  • Quality system setup and improvement
  • SOP, instruction and document infrastructure
  • Setting up and running a training system
  • Deviation, change control and CAPA management
  • Quality processes for stem cell and advanced therapy units
  • Aligning ISO 9001 with GMP

Project Consulting & Management

New facility set-ups, quality transformation projects and technical operations management. An integrated approach.

  • New facility set-up and licensing processes
  • GMP compliance transformation projects
  • Quality system revision projects
  • Flexible, project-based working model
  • Coordination of multidisciplinary technical teams
  • Preparation of technical files and document packages

Let's identify the gaps in your current system together

Modular consulting from gap analysis to certification readiness.

Request a Gap Analysis