We provide comprehensive local pharmacovigilance (PV) services to international pharmaceutical companies and Marketing Authorisation Holders (MAHs) operating in Georgia. Our team ensures compliance with pharmacovigilance requirements while supporting the maintenance of high standards of patient safety and regulatory compliance

* Appointment of a Lead Local Safety Officer (LSO)
* Continuous support and communication with local regulatory authorities
* 24/7 availability where required by contractual arrangements





We would be pleased to discuss your local pharmacovigilance requirements and develop a customized service package for your organization
For further information, please contact us: info@cophh.ge

Local Case Management:

* Receipt and processing of AEs and local Individual Case Safety Reports (ICSRs)
* Quality review and follow-up activities
* Submission of ICSRs to the Georgian Competent Authority, where applicable
* Compliance with local reporting timelines and requirements

Local Literature Monitoring:

* Weekly monitoring of Georgian scientific and medical literature
* Identification of potential adverse drug reaction reports and safety information
* Documentation and communication of relevant findings to the MAH

Regulatory Intelligence and Compliance:

* Continuous monitoring of local pharmacovigilance legislation and regulatory developments
* Assessment of regulatory changes and their impact on MAH obligations
* Timely communication of relevant updates and recommendations

Support for Risk Management Activities:

* Local support for Risk Management Plans (RMPs)
* Assistance with implementation and maintenance of local risk minimization measures
* Support in handling aggregate reports
* Coordination with global pharmacovigilance teams

Training:

* Initial and periodic pharmacovigilance training for local personnel
* Customized training programs for commercial, medical, regulatory and quality teams
* Training documentation and compliance records