Consulting, Service &
Compliance Management

We provide our clients with both consulting and operational services.


GxP - Consulting & support

  • QM support
  • Training systems
  • Audits, mock audits, compliance tests, audit preparations
  • Developing and Preparing customized qualification and validation concepts
  • Quality risk management
  • Preparing GMP (Good Manufacturing Practice) documents (Site Master File, master plans, RA, DQ, IQ, OQ, PQ)
  • Directing GMP projects
  • Coordinating interdisciplinary validation of major projects
  • Developing GxP-compatible QS systems
  • Supplier quality management
  • Consulting on GxP subjects including accompanying standards and guidelines
  • Qualification and validation strategies

Legal information system (RIS)

  • Legal claims system
  • Comprehensive legal register
  • Regulatory amendments
  • Legal compliance checks

Industrial and operational plant law

  • Self-reviews in accordance with §82b Austrian Trade Regulations (GewO)
  • Industrial and operational plant authorization
  • Public authority mentoring
  • Information requirements

Recurrent testing

  • Due diligence according to operating material regulations (AMV)

Biosafety

  • Handling of microorganisms
  • Bio-safety officer
  • Bio-safety program
  • Genetic engineering legislation
  • Epizootic disease legislation
  • Decontamination

Management systems and auditing

  • Process integrated management
  • Quality management
  • Environmental management
    Health & safety management
  • ISO 9001
  • ISO 14001
  • ISO / IEC 15504 SPICE
  • BS 8800
  • OSHAS 18000
  • SHE Management
  • SCC