STM Pharma PRO’s manufacturing workshop has a dedicated area for manufacturing activities, providing manufacturing services in compliance with EU-GMP / CGMP.

• Production of placebo capsules by filling with inert excipient
• Masking of IMPs by overencapsulation of solid oral formulations
• Distribution of active ingredient in capsules
• Production of technical and experimental batches
• Production of placebo tablets through a validated external partner
• Batch release and QP certification

Primary and secondary packaging of drugs for experimental clinical use are the core activity of STM PHARMA PRO’s pharmaceutical workshop.

• Blistering of solid oral formulations in PVC/PVDC/ALU and in ALU/ALU
• Blistering of solid oral formulations
• Secondary packaging and packaging of all types of formulations
• Ad hoc packaging design according to customer and clinical trial requirements
• Provision of user-friendly packaging materials checked to meet quality specifications

Expertise, high responsiveness, flexibility and wide range of options for IMP distribution in Italy, Europe and worldwide

• Shipment preparation within 24 hours after receipt of request
• Shipments at 2-8°C and 15-25°C by dedicated courier, delivery within 24h (maximum 72h)
• Controlled and uncontrolled temperature shipments by express courier, 24-hour delivery throughout Europe
• Just-in-time delivery (Italy: 12-24h; Abroad: 24-72h)
• Monitoring of transport conditions via disposable data loggers
• Use of validated boxes for temperature-controlled shipments
• Use of specific shipment/delivery forms for Clinical Trials
• Management of allocation requests and IMP resupply via IXRS, email, or fax
• Delivery confirmation via system and paper POD by Investigators
• Tracking of request and shipment status
• Distribution in US, Russia, and Australia through local depots
• Import/export customs processing