Georgia is rapidly emerging as a highly attractive location for conducting clinical trials, offering a streamlined regulatory environment, cost-efficiency, and high-quality data acceptable to both the FDA and EMA. Our firm provides expert legal guidance to international pharmaceutical companies, biotech innovators, and contract research organizations (CROs) seeking to leverage Georgia's favorable conditions. We offer comprehensive support to ensure your clinical research is conducted in full compliance with Georgian law and the highest international standards, facilitating a smooth and efficient path from submission to approval.
The legal framework for clinical trials in Georgia is principally governed by the Law of Georgia on Drugs and Pharmaceutical Activities. The primary regulatory authority is the LEPL State Regulation Agency for Medical and Pharmaceutical Activities, which operates under the Ministry of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs of Georgia. Our legal experts possess an in-depth understanding of these regulations and maintain professional relationships with the regulatory bodies, ensuring your application dossier is meticulously prepared to meet all statutory requirements.
Navigating the approval process in Georgia requires a clear, strategic approach. The procedure involves a two-step review, beginning with a positive opinion from a Local Ethics Committee, followed by the submission to and approval from the State Regulation Agency. This entire process is notably efficient, typically concluding within approximately two months, making Georgia one of the fastest jurisdictions for initiating clinical research. Our role is to manage this process on your behalf, coordinating all submissions and communications to prevent delays and ensure a timely study launch.
Successful regulatory submission hinges on precise documentation and adherence to international standards, including the ICH Guidelines for Good Clinical Practice (GCP). The required dossier includes the Clinical Trial Protocol, Investigator's Brochure, subject information sheets, and proof of insurance, among other documents. It is critical to note that key patient-facing documents must be submitted in the Georgian language. We manage the entire documentation lifecycle, from legal review and adaptation to overseeing certified translations, guaranteeing that your submission package is flawless and fully compliant.
Our Clinical Trials Regulatory Compliance service is designed to provide end-to-end legal support. This includes acting as your mandatory local legal representative in Georgia, preparing and submitting the complete application for the clinical trial permit, and liaising directly with the Ethics Committee and the State Regulation Agency. We handle all clarification requests from the authorities, provide ongoing legal oversight for the duration of the trial, and ensure all activities remain aligned with the approved protocol and Georgian legislation. By entrusting us with your regulatory compliance, your organization can focus on the scientific and operational execution of your clinical trial with confidence.
Updated: ...