Quality Assurance

Plant based medicines are complex products. The quality is influenced by many  factors at all stages of the product life cycle. Our experienced team of plant based medicines experts are familiar with the challenges from the identification & qualification of reliable suppliers  to the constant quality assurance of your product portfolio. Benefit from our partners network in the life science industry and outsource solutions to our core team.

​

Quality assurance consulting services include but are not limited to:

​

• Identification & qualification of suppliers

• Supplier audits (paper based & on site)

• Internal audits 

• Design of stability testing (sampling, amount, duration, conditions)

• SOP’s (writing/approval) 

• Feedback & sparring on IQ/OQ/PQ

• Equipment & process validation

• Competent Person (CP) / Qualified Person (QP) 

​

Regulatory Affairs

​

The regulatory environment for medical cannabis differs from country to country. Meeting national & EU standards can be challenging and is at the same time the most crucial success factor for your cannabis company. 

Applying for licences and products can be a lengthy bureaucratic process with nonlinear workloads spread over months.

Benefit from on demand capacities to cover workload peaks and avoid high salary obligations for in-house experts during the authorities’ processing periods of your applications.

​

Regulatory consulting services include but are not limited to:

​​

• Company authorizations

• Licence applications

• Product applications

• Creation and submission of data package for market registration

• Narcotic / euphoric substances accounting & reporting

• Import and export regulation

• Competent / qualified person

• Feedback & sparring on projects

• Guidance in national and international legislation on medicinal cannabis

​