Qualification and validation

Focusing on quality of products

We have many years of experience as consultants to the pharmaceutical industry and the medical device industry.

We carry out design according to cGMP and qualification and validation of locations and production facilities in order to achieve approval from European authorities and the FDA.

The tasks are always carried out in close collaboration with our clients and we adapt our work to the client’s standards and to the authorities’ requirements.

Our consultants can assist with:

  • Requirement specifications
  • Regulatory requirements
  • Risk assessment
  • Quality assurance and auditing
  • DQ, IQ, OQ, PQ
  • PV, VMP

“We aid your company in documenting production in continuous accordance with quality requirements”

Contact info

Kim LauritzenProject DirectorAllerødT: +45 4810 4658E: Send E-mail
Lene Holst KjærgaardBusiness Unit DirectorAllerødT: +45 4810 4401E: Send E-mail
Further contact info
© NIRAS Gruppen A/S - Sortemosevej 19 - 3450 Allerød - Denmark - T: +45 4810 4200 - F: +45 4810 4300 - E: niras@niras.com - Sitemap - NIRAS Gruppen A/S CVR: 73432219

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