Importer of Record for Clinical Trials for Pharmaceutical Companies and Clinical Research Organisations with no registered company in South Africa
New trial applications to:
- the South African Health Products Regulatory Authority (SAHPRA) to obtain approval and import license for Investigational Product,
- various Ethics committees, e.g. Pharma Ethics.
Collation, submission and tracking of:
- Safety Reporting to the South African Health Products Regulatory Authority (SAHPRA),
- annual re-approvals for clinical trials to ethics committees,
- six-monthly progress reports, including global blinded SUSAR and SAE line listings,
- unblinded safety reporting.
Applications for approval and renewal of export permits.
General regulatory and ethics correspondence and tracking thereof.
Zenith Clinical Research Consulting (Pty) Ltd was founded in 2012.
We offer Importer of Record services (Duty Delivery Paid - DDP) to Pharmaceutical Companies and Clinical Research Organisations with no registered entity in South Africa.
Zenith manages the import of Investigational Product/study drug and all associated clinical trial supplies, i.e. laboratory kits and electronic equipment in accordance with applicable customs regulations.
Importer of Record
Zenith serves at the Importer of Record for:
Clinical Trial Equipment & Supplies