Pharmaceutical Development

Product Support

  • Forming a link between client and machine supplier
  • Support of prototype development
  • Life-Cycle Management support


  • Design transfer from test phase to production phase
  • Implementation of individual requirements

Process Support

  • Analysis of current process workflows
  • Establishment of GMP-conform process workflows
  • Interface Management

Compliance Support

  • Structuring of technical, process and quality management documentation
  • Qualification and validation of production- and control-plants and systems
  • GMP training of employees

Process-based Risk Management


  • Establishment of a risk analysis strategy
  • Risk analysis of GMP plants
  • Risk analysis of computer systems


  • Process development via the QbD approach that helps implementing ICH quality guidelines Q8 and Q9
  • Application of the QbD risk analysis as combination of probability
    and severity of the considered risk
  • Adaption to the relevant risk


  • Analysis of existing process workflows
  • Establishment of a top-down risk management
  • Specification of problems

PQR – Product Quality Review

  • Refurbishment of existing data
  • Establishment of product quality review for easy process specifications verification

Quality Management

Qualification Support

  • Preparation of qualification documentation
  • Implementation of initial qualifications
  • Employees and plant qualification

Validation Support

  • Preparation of validation documentation
  • Validation of document management software
  • Validation of monitoring systems

Life-Cycle Management

  • Support of the prototype development
  • Support of the whole Life-Cycle Management process
  • Establishment of documentation software


  • Audit preparation
  • Audit execution

Project Management

Process Buildup

  • Buildup of new processes and operations
  • Analysis of existing processes
  • Expansion and reconstruction of existing processes

Project Management Assessment

  • Analysis of existing process workflows considering optimizing potentials
  • Planning of process optimization
  • Implementation of process optimization

Phase Conception

  • Demonstration of process phases
  • Structuring of process phases
  • Implemention of process phases