GMP Compliance & Quality Systems

Design & Process Improvement

Our services

Compliance by Design.
We apply a science & risk-based approach to every single project we deliver.
We join your technical team providing value and knowledge. Those are the services we provide.

smart qbd

SMART QbD

  • Quality by Design training & support
  • Process risk analysis
  • Design of experiments

LIFECYCLE VALIDATION

  • PPQ Protocols/Reports
  • CPV plans/statistical support
  • Cleaning Validation
GxP & MEDICAL DEVICES

GxP & MEDICAL DEVICES

  • GMP Quality Systems & Audits
  • ISO 13485, ISO 14971
  • Data Integrity
opex pharma

OPEX PHARMA

  • Lean Six Sigma projects
  • Process improvement
  • Six Sigma training  “in company”
pharma laboratory

LABORATORY

  • Analytical QbD
  • Lab Data Integrity
  • Lean Laboratory
specialised training

SPECIALISED TRAINING

  • QbD, Risk Analysis, DoE
  • Applied statistics
  • GxP Compliance

We have worked for…

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