Services

Quality control & microbiology

Independent, GMP-compliant pharmaceutical testing from our fully accredited laboratory in Oirschot — for both veterinary and human pharmaceutical products.

Quality control laboratory at Regivet
Our role

Reliable independent testing you can submit with confidence

Our laboratory team of analytical chemists and microbiologists provides the full range of pharmaceutical quality control testing required for development, batch release and regulatory submissions.

As an independent laboratory — not affiliated with any manufacturer — our results carry the credibility that regulators expect. We hold MIA authorisations for both veterinary (2924-F) and human (109627 F) pharmaceutical products.

GMP certified facility
Ph.Eur. and USP methods
MIA vet & human
Results within agreed timelines
Chemistry

Analytical chemistry testing

Our analytical chemistry suite is equipped with HPLC, GC, ICP-OES, UV/Vis and Karl Fischer instrumentation — covering the full range of physicochemical testing required for pharmaceutical batch release and development.

  • Identity and assay (HPLC, GC, UV)
  • Related substances and impurity profiling
  • Dissolution and disintegration testing
  • Karl Fischer moisture determination
  • ICP-OES elemental analysis
  • pH, viscosity and osmolality
  • Particle size and appearance
  • Batch release analysis
Analytical chemistry laboratory at Regivet Oirschot
Microbiology laboratory at Regivet
Microbiology

Microbiology laboratory services

Our dedicated, ISO-controlled microbiology suite operates with laminar flow cabinets, incubators and aseptic workstations. All testing is performed to current Ph.Eur. standards by our qualified team of microbiologists.

  • Sterility testing (membrane filtration & direct inoculation)
  • Bacterial endotoxins — LAL gel clot & kinetic
  • Microbial limit testing (TAMC & TYMC)
  • Antimicrobial efficacy testing
  • Environmental monitoring programs
  • Water quality analysis
  • Bioburden determination
Stability

Stability studies

Dedicated walk-in and bench-top stability chambers with continuous temperature and humidity monitoring. We run VICH and ICH-compliant stability programs with automated data logging, alarm systems and full GMP documentation.

  • Long-term stability (VICH GL3 / ICH Q1A)
  • Accelerated stability conditions
  • Intermediate storage studies
  • Photo-stability (ICH Q1B)
  • Freeze-thaw cycling studies
  • In-use stability
Stability storage chambers at Regivet laboratory
Accreditation

GMP certificates

Our laboratory holds Manufacturing and Import Authorisations for both veterinary and human pharmaceutical products, confirming full compliance with EU Good Manufacturing Practice requirements.

MIA veterinary — 2924-F

Manufacturing and import authorisation for veterinary pharmaceutical products, issued under EU GMP regulations by the Dutch competent authority.

Download

MIA human — 109627 F

Manufacturing and import authorisation for human pharmaceutical products, confirming compliance with EU GMP requirements for human medicines.

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Ready to discuss your testing requirements?

Our laboratory team will assess your testing needs and provide a tailored proposal — typically within 2 working days.

Get in touch