The regulatory division in our company offers a wide range of regulatory services to our clients that cover Global regulatory consultancy/submissions, obtaining approvals from authorities forclinical trials, registration dossier submissions and follow up, pharmacovigilance and import/export license for drugs, IMPs, bio-samples and other study materials.
We offer a complete logistics and reverse logistics solution for Clinical Studies including Investigational Medicinal Products and Biological materials were we assess the necessary documents needed and obtain the required approvals from the authorities for import/export and clearance.
Our storage facility is GMP compliant with controlled temperature/humidity containing ambient and refrigerated storage areas,equipped with a double backup system for power, monitored 24/7 with CC system including night vision and motion sensors, firefighting and fire alarm system with local and remote alarm capabilities.
The depot has a well-established inventory and tracking system is with complete SOPs and forms covering all operations like: Import/Export, Receipt, Labeling/Relabeling, Distribution, Transport, Return, Reconciliation, Recall, and Destruction.
Locally Lebanon, regionally MENA and GCC are covered by our distribution service that offers fast and secure delivery under controlled temperature conditions. Also local purchase of available comparator drugs, study materials and devices
Central laboratory services that includePlanning, organization and distribution of lab kits, sample labels, documents and forms to investigational sites and sample logistics of all kind of body fluids for safety/efficacy testing as well as for PK, and biomarker assessments, and result distribution.