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 on:

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