What can CD Log add to handling your CT supplies?

Regulatory

Compliance with Regulations and Standards

Compliance with local regulations and with international standards, such as Good Clinical Practices and Good Storage and Distribution Practices.

Successful Regulatory Submissions

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. 

Cooperation with Local Health Authorities

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.

Regulatory Services

Importation & Exportation

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

Recall

Product Recall

Product Recall done as per local applicable Regulations

Labeling

Over-Labeling Approval

Health Authorities Approval for Over-Labeling for IMP Shelf-Life Extension

Other

Other Regulatory Services

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