Our company offers a full range of services to support the pharmacovigilance system, meeting the requirements of Ukrainian and international legislation. We help pharmaceutical companies create an effective system that will ensure the safety of their products and consumer trust.

Our main services:

• Establishing and maintaining a pharmacovigilance system: Developing standard operating procedures (SOPs), preparing all necessary documentation and keeping it up to date.

• Information collection and processing: Establishing a process for collecting data on adverse reactions from healthcare professionals, patients and other sources. We ensure the fast and accurate processing of this information.

• Submission of reports to government agencies: Proper and timely submission of reports on adverse reactions to the State Expert Center of the Ministry of Health of Ukraine.

• Report preparation: Preparation of periodic safety reports (PSUR/PBRER) as well as other required documents.

• Audit and Inspection: Conducting internal audits to verify your system’s compliance with regulatory requirements.

Why choose us?

• Expertise: Our team consists of qualified specialists who have in-depth knowledge in the field of pharmacovigilance and drug registration.

• Comprehensive approach: We provide full support — from initial system setup to ongoing support and reporting.

• Compliance: We guarantee that your pharmacovigilance system will comply with all relevant requirements of Ukrainian, EU legislation and international standards.

• Reliability: You can be sure that your documentation will be flawlessly executed and all deadlines will be met.

Entrust us with overseeing the safety of your medicines and we will help you ensure their effectiveness and patient trust. Contact us to learn more about our services.