Our Approach
There is a consensus on the point that Medical Cannabis offers practical, safe and well-tolerated alternative treatment. We, then, have developped a unique expertise in Europe in this cutting-edge field, based on our core technical skills.
From advising on risk management systems, through to engineering cleanrooms and extractions solutions, Apotech has become recognised as one of Europe’s leading medicinal cannabis consulting firms for high-quality pharmaceutical production that are compliant with GACP, EU-GMP and PIC/S.
GACP: Good Agricultural and Collection Practices
• Documentary Audits
• Accreditation to ISO/IEC 17025
• Cultivation, Harvest & Collection strategy
• CAPA Plans Development
• Development or Review of SOPs
• Support on the GACP certification to obtain
EU-GMP: Good Manufacturing Practices
• Writing of Quality Management System ISO9001
• EU-GMP Audits
• CAPA Plans Development
• Development or Review of General & Specific SOPs
• Support on Dossier Preparation & submission to the Regulatory Bodies
• Support on interpretation & resolution of Regulatory Bodies observations
Other Services
• Engineering design (greenfield or brownfield)
• Supply chain: from harvest to shipment
• Packaging
• Scientific communication & advice
