PharmExpert LLC was founded in 2019 and has expanded steadily from a single-country operation to a ten-country international presence by 2024, with ongoing expansion in progress. The company operates as a dedicated pharmacovigilance outsourcing and consulting services provider, serving pharmaceutical, biotechnology, and clinical research organisations that market or intend to market medicinal products in the Commonwealth of Independent States (CIS) and Eurasian Economic Union (EAEU) regulatory jurisdictions.

The company’s geographic coverage spans Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan — a portfolio of markets characterised by country-specific regulatory requirements, distinct national pharmacovigilance reporting obligations, and regulatory frameworks that are materially different from those of the EU or US, requiring specialist local expertise that most global pharmacovigilance CROs are not equipped to provide in depth.

PharmExpert operates its quality management system in accordance with GVP (Good Pharmacovigilance Practice) guidelines. The company is available in English and Russian, reflecting its primary client base of both Western pharmaceutical companies entering the CIS/EAEU region and domestic Russian-speaking manufacturers.

Key Products and Services

QPPV and Local Qualified Person for Pharmacovigilance

• Provision of Qualified Person for Pharmacovigilance (QPPV) services for global and regional pharmacovigilance system oversight
• Local Qualified Person for Pharmacovigilance (LQPPV) and Local Contact Person for Pharmacovigilance (LCPPV) representation across all ten covered CIS/EAEU jurisdictions, ensuring local regulatory compliance and point-of-contact availability for national competent authorities

Pharmacovigilance System Establishment and Management

• Design, implementation, and ongoing management of compliant pharmacovigilance systems for pharmaceutical companies entering or operating in CIS/EAEU markets
• Pharmacovigilance System Master File (PSMF) development and maintenance
• Pharmacovigilance Quality System design and management aligned with ISO 9001:2015 and GVP guidelines
• Full outsourcing of pharmacovigilance system operations for client organisations

Adverse Event Processing

• Individual Case Safety Report (ICSR) receipt, processing, medical assessment, and submission to national competent authorities within country-specific regulatory timeframes
• Safety database (SDB) management and maintenance for client products across covered jurisdictions
• Spontaneous reporting system management, including collection from healthcare professionals, patients, licence partners, and distributors

Aggregate Safety Reporting

• Preparation and submission of Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) to national competent authorities across CIS/EAEU markets
• Development Safety Update Reports (DSURs) for investigational medicinal products in clinical development

Signal Detection and Management

• Systematic signal detection, assessment, and management using quantitative and qualitative methods from spontaneous reporting databases and literature
• Benefit-risk ratio assessment and signal evaluation in response to emerging safety information

Risk Management Plans and Risk Minimisation

• Preparation and maintenance of Risk Management Plans (RMPs) aligned with national regulatory requirements across covered jurisdictions
• Risk Minimisation Measures (RMM) implementation, including routine and additional risk minimisation activities
• Additional Risk Minimisation Measures (aRMM) such as healthcare professional communications, patient alert cards, and educational materials

Literature Monitoring and Regulatory Intelligence

• Systematic pharmacovigilance literature monitoring of scientific publications for safety-relevant information across all marketed products
• Regulatory intelligence monitoring — tracking of regulatory updates, guideline changes, and competent authority communications across CIS/EAEU markets relevant to client products
• Marketing authorisation status review across covered jurisdictions

National Competent Authority Interactions

• Management of requests from national pharmacovigilance centres and competent authorities across covered markets
• Pharmacovigilance inspection readiness preparation and support during regulatory inspections
• Liaison with national pharmacovigilance centres and national competent authorities on behalf of client marketing authorisation holders

Medical Information Services

• Medical information request handling and response for healthcare professionals and patients in covered markets, in compliance with local regulatory requirements

IT and Information Security

• Computerised System Validation (CSV) support for pharmacovigilance systems and safety databases
• Information security consultancy for pharmacovigilance data management in compliance with applicable data protection requirements

Post-Authorisation Safety Studies (PASS)

• Protocol development, regulatory submission, conduct oversight, and reporting of post-authorisation safety studies in CIS/EAEU markets

Training

• Pharmacovigilance training programmes for client employees and stakeholders on GVP requirements, adverse event reporting obligations, and country-specific regulatory frameworks

PharmExpert occupies a well-defined and underserved niche within the global pharmacovigilance services market: specialist coverage of CIS and EAEU regulatory jurisdictions, a cluster of markets that present genuine pharmacovigilance compliance complexity yet are routinely underserved by large global pharmacovigilance CROs whose CIS/EAEU expertise is shallow relative to their EU and US capabilities. Pharmaceutical companies with products registered in Russia, Kazakhstan, Ukraine, or other CIS/EAEU markets face country-specific adverse event reporting timelines, local language submission requirements, national competent authority relationships, and regulatory frameworks that diverge meaningfully from ICH-aligned international standards — creating a practical demand for specialist local pharmacovigilance representation that PharmExpert is structured to provide. Founded in 2019 and expanding to ten-country coverage within five years through organic geographic build-out, the company demonstrates a focused growth strategy consistent with deepening regional expertise rather than broadening into more competitive global markets. Its ISO 9001:2015 certification and GVP-aligned quality system provide a credibility foundation appropriate for pharmaceutical company supplier qualification.