Compliance with local regulations and with international standards, such as Good Clinical Practices and Good Storage and Distribution Practices.
CD Log's experienced staff offers invaluable support in navigating the complexities of implementing a clinical trial. By providing expert guidance and assistance, we ensure that regulatory challenges are effectively addressed, resulting in timely submissions, efficient approvals, and swift study initiation.
CD Log prides itself on maintaining a strong and trusted relationship with the local Regulatory Authorities in Lebanon. This is achieved through our deep understanding of the Lebanese regulatory framework and our commitment to staying up-to-date with the latest applicable regulations. By staying informed and compliant, we ensure a seamless interaction with regulatory bodies, fostering a reliable and compliant environment for our clients' clinical trials.
Import and Export Licenses for IMP
Handling of regulatory approvals for importation/exportation of Biological Samples
Importation, approvals, and clearance of: ancillaries, medical devices and equipment, e-diaries and electronic equipment
Product Recall handled as per local regulations
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