Compliance with local regulations and with international standards, such as Good Clinical Practices and Good Storage and Distribution Practices.
CD Log's staff provides assistance to address the regulatory challenges encountered during the implementation of a clinical trial, leading to timely submissions, approvals, and rapid initiation of a study.
CD Log maintains a trustworthy relationship with the local Regulatory Authorities thanks to a profound understanding of the Lebanese regulatory framework, keeping up updated with the latest applicable regulations.
Import and Export Licenses for IMP
Handling of Regulatory Approvals for Importation/Exportation of Human Biological Samples
Importation, Approvals, and Clearance of: Ancillaries, Medical Devices, E-diaries and Electronic Equipment
Product Recall done as per local applicable Regulations
Health Authorities Approval for Over-Labeling for IMP Shelf-Life Extension
Data Entry and Submission of Clinical Trial Application on the Lebanese Clinical Trial Registry (LBCTR)
Safety Reports Submission to local Health Authorities (SUSAR, SAE, DSUR, 6MLL...)
Regulatory Submission of Annual Safety and Progress Reports to local Health Authorities
Importation of IMP for Compassionate Use and Expanded Access Programs
Regulatory Consulting Services for Marketing Authorization Application