On-going Services

Packaging, QP certification/QP-re-certification, storage and distribution are the main clinical trial supply activities once the supply is sourced or imported.
Each protocol has its unique challenges including supply expiration date, cost and storage conditions. All these challenges require close monitoring and careful planning to ensure adequate supply level at all times in all participating sites and countries.



IMP manages overall required packaging materials, printed or not, according to pre-defined specifications while complying with Israeli and global packaging regulation.
Complete packaging services include:

  • Primary packaging (OSD)
  • Secondary packaging, including randomized kit assembly (manipulation) for double blind studies.
  • Planned cytotoxic labeling
  • Packaging adjustments, relabeling
  • Expiry date extension both at IMP and at study sites
  • Packaging at refrigerated conditions





Dedicated, access controlled areas for starting materials and for finished products to ensure correct flow of activities and to mitigate mix-ups.
Storage at freezing conditions (-25oc to -15oc), refrigerated conditions (2oc to 8oc) and controlled room temperature (15oc to 25oc)

QP Services


IMP offers in-house QPs dedicated to your study, with extensive experience in clinical batch certification
In compliance with published regulation of Manufacture and Import of IMPs in the state of Israel (EX-012/ 01), each batch of product intended for use in a clinical trial (III, IV) requires QP certification/recertification.




Robust distribution to study sites in Israel and abroad
Distribution to study sites in Israel is performed using validated shippers, validated Vehicles with urgent shipment service.
In cases of exportation, global qualified sub-contractors are used according to customers requirement.