Services

Everything a regulated facility needs
to go into operation — and stay there.

Four disciplines, delivered by senior experts and connected in one workflow. Each engagement ends the same way: with documentation your QA team, and your inspector, can rely on.

/ C&Q

Commissioning & Qualification

From user requirements to proven performance — planned risk-based, executed on site, documented digitally.

Hygienic stainless-steel piping with valves and pressure gauges during qualification of process utilities Utility Qualification
  • Commissioning planning & execution
  • Equipment qualification (DQ / IQ / OQ / PQ)
  • Facility & cleanroom qualification
  • Utility qualification (WFI, purified water, clean steam, HVAC, gases)
  • System qualification & start-up support
  • Requalification & periodic review
  • CQV master planning (ASTM E2500)
  • URS development & design review

/ CSV · PV · CV

Validation

Risk-based validation strategies that satisfy Swissmedic, EMA and FDA — without gold-plating.

Ampoule filling and sealing line in pharmaceutical production — process validation environment Process Validation
  • Computer system validation (CSV)
  • GAMP 5 (2nd Edition) implementation
  • 21 CFR Part 11 / Annex 11 compliance
  • Process validation (EU & FDA expectations)
  • Cleaning validation & verification
  • Validation master plans & strategies
  • Validation documentation & protocols
  • Data integrity assessments

/ GMP

GMP & Quality Compliance

Pragmatic compliance support — from Annex 1 remediation to inspection readiness.

GMP-compliant handling of pharmaceutical ampoules by an operator in full cleanroom garment GMP Compliance
  • GMP consulting & gap analyses
  • EU GMP Annex 1 readiness & CCS support
  • Quality management system support
  • Quality assurance on site (interim & project-based)
  • Audit & inspection readiness
  • Deviation & CAPA support
  • GMP training (basics, Annex 1, data integrity)
  • Regulatory compliance monitoring

/ PM · ENG

Engineering & Project Support

Technical backbone for your CapEx project — so engineering and quality move in step.

Engineer with hard hat and tablet during site inspection — engineering and commissioning support Site Engineering
  • Project management & planning
  • Engineering support during design & execution
  • Technical documentation
  • Construction & installation supervision
  • Start-up / commissioning support
  • Vendor & contractor coordination
  • Tech transfer support
  • Expert leasing (senior GxP professionals)

Engagement Models

Three ways to work with us. All of them predictable.

Open-ended consulting invoices are a risk you shouldn't have to carry. Our engagement models are built for budget clarity.

Fixed fee

CQV Sprint

A fast, structured entry point: we assess where you stand and what your project needs — typically within two weeks.

  • Gap analysis & risk assessment
  • CQV master plan
  • Prioritised action roadmap
  • Fixed price, defined duration
Project

Qualification & Validation Project

Full execution for a defined scope — a system, a line, a facility — from protocol to signed report.

  • DQ / IQ / OQ / PQ execution
  • CSV, process or cleaning validation
  • Digital, audit-ready documentation
  • Milestone-based fixed pricing
Retainer

GMP Routine Support

Continuous access to senior QA / validation capacity — without building an internal team.

  • Defined days per month
  • Deviations, changes, periodic reviews
  • Audit readiness maintained
  • Monthly flat rate

Scope and pricing are defined per engagement after an initial assessment. Request a proposal →

Next step

Let's discuss your next project.

Describe your system, your timeline or your compliance gap — we usually reply within 48 hours.

Discuss a Project