International Pharmacovigilance for Comprehensive Drug Safety
PharmExpert' International Pharmacovigilance Processes are Presented in the Pharmacovigilance System below. Click the blue buttons to get more information.
Our International Pharmacovigilance Solutions
PharmExpert LLC provides a comprehensive range of international pharmacovigilance services to meet your global needs in the territories of Azerbaijan, Belarus, Georgia, Russia, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.
- QPPV and Local QPPV
- PSMF Management
- Literature Monitoring and Aggregate Reporting (PSURs, DSURs)
- Regulatory Intelligence Monitoring
- ICSR Management and Assessment of Benefit-Risk Ratio
- Local Contact Person for Pharmacovigilance (LCPPV)
- Risk Management Plans (RMPs) and Risk Minimization Activities
- Pharmacovigilance Audit and Inspections
- Pharmacovigilance Trainings
- Safety Database and Signal Management
- Medical Information Requests
- Post-Authorization Safety Studies (PASS)
- Outsourcing of Pharmacovigilance System.
No matter where your product is marketed in CIS/EAEU, our dedicated team ensures compliance with country-specific regulations, providing end-to-end support throughout the product lifecycle.
Looking for a Top Quality International Pharmacovigilance Consultant?
About Us: Your Trusted Partner in International Pharmacovigilance
PharmExpert is your trusted partner in delivering world-class international pharmacovigilance solutions, ensuring the safety and efficacy of medicinal products across global markets. Our expertise spans diverse therapeutic areas, with a focus on compliance in CIS and EAEU regions. From adverse event reporting to risk management planning, we provide tailored strategies to meet the unique challenges of international regulatory environments. At PharmExpert, we prioritize patient safety while empowering pharmaceutical companies with seamless, efficient, and compliant solutions throughout every stage of the product lifecycle.
Our Expertise
At PharmExpert, we empower healthcare businesses with advanced pharmacovigilance solutions tailored to meet the evolving needs of the pharmaceutical industry. Our commitment lies in ensuring stringent regulatory compliance and safeguarding patient safety through innovative and effective approaches. We specialize in a comprehensive suite of services, including meticulous monitoring, precise reporting, and insightful analysis of drug safety data. Our methodologies are designed to foster trust and transparency, bridging the gap between healthcare providers, regulatory authorities, and patients.
Our Key Aim
At PharmExpert, we are committed to excellence in every aspect of our operations. Our cornerstone is a robust Quality Management System meticulously designed and maintained in accordance with the internationally recognized ISO 9001:2015 quality standard and the rigorous pharmacovigilance GVP guidelines. This unwavering commitment reflects our dedication to ensuring the highest standards of quality, safety, and efficiency. Our key aim is not only to ensure the flawless execution of our processes but also to set benchmarks in quality management within the pharmacovigilance domain. Together, we strive to build a safer, more efficient future for healthcare systems worldwide.
Our main objectives
In line with this strategic vision, our main objectives are: 1) To provide adequate, reliable and regulatory compliance solutions; 2) Optimize the performance of Company’s business and pharmacovigilance processes by maintaining continuous improvement of Quality Management System; 3) Effectively address and satisfy any existing and projected needs of educational, training and professional development needs of employees and other stakeholders of the Company; 4) Build client loyalty by meeting or exceeding our customer expectations and contractual obligations.
PharmExpert' International Pharmacovigilance Stat.
Active PV Projects
Satisfied Companies
SDEA Compliance
Regulatory Compliance
Why Choose PharmExpert for International Pharmacovigilance?
PharmExpert brings unmatched expertise in international pharmacovigilance by combining industry-leading technology, deep regulatory knowledge, and a client-centric approach. Our commitment to transparency, efficiency, and compliance makes us a trusted partner for pharmaceutical companies worldwide. We stay ahead of evolving regulatory standards to provide innovative solutions tailored to your needs.
We care for our clients’ business as our business. We think and act like business partners, not academic advisors. We share our clients’ aspirations, work to understand their reality, and align our incentives with their objectives — so they know we’re in this together.
Our Commitment to Compliance
We ensure seamless compliance with international regulatory frameworks, including EMA, FDA, and WHO guidelines. By collaborating closely with local regulatory authorities in CIS and EAEU regions, we enable smooth market access and continued product safety monitoring.
Global Reach, Local Expertise
Our network of qualified professionals spans the globe, offering both centralized and localized pharmacovigilance solutions. From QPPV representation to comprehensive risk management plans, our team is dedicated to supporting your operations across borders.
Continuous Improvements
We are a company that optimizes the performance of our business and international pharmacovigilance processes by maintaining continuous improvement of Quality Management System.
Local QPPV
Trusted local representatives ensuring compliance in key regions. Embrace the future of international pharmacovigilance with us.
Customer satisfaction
We are an international pharmacovigilance consulting provider that designs and builds client loyalty by meeting or exceeding our customer expectations and contractual obligations.
Professional Development and Trainings
We are a company that effectively addresses and satisfies any existing and projected needs of education, training and professional development of employees and other stakeholders of the Company.
Adverse Event Reporting
Streamlined systems for timely and accurate reporting in compliance with international standards.
Risk Management Plans
Robust strategies to minimize risks and ensure safe product usage.
Our Clients
Don’t Just Take Our Word for It
FAQ
Ask Us Anything About International Pharmacovigilance
Why pharmacovigilance is so important?
Pharmacovigilance is crucial for ensuring drug safety by detecting, assessing, and preventing adverse drug reactions (ADRs), especially post-marketing. It identifies rare or long-term side effects, enhances public trust, ensures regulatory compliance, and reduces healthcare costs. Pharmacovigilance supports risk-benefit analysis, improves patient safety, and helps detect medication errors. Overall, it protects public health and promotes safer, more effective medicines.
What is a pharmacovigilance system?
it’s a system that helps track and manage the safety of medicines once they’re in use by people, ensuring that any new problems or risks are identified and addressed promptly. You may check the flowchart on the top of this page to better understanding how the PV system run.
How much do the services cost?
Thank you for your inquiry. To provide you with an accurate and competitive quotation, we kindly request that you share the details of your pharmacovigilance project. Understanding your specific requirements will allow us to tailor our services to your needs and offer you the optimal balance of quality and cost. We are committed to delivering the best value while maintaining the highest standards of service.
What is your experience level?
We are a dedicated pharmacovigilance consulting services provider with a strong track record of expertise and reliability. Our team comprises highly qualified professionals with 5-10 years of combined experience in pharmacovigilance, regulatory compliance, and risk management. We have successfully supported a diverse range of clients, including pharmaceutical, biotechnology, and clinical research organizations, ensuring the safety of medicinal products across global markets. Our comprehensive services cover case processing, signal detection, risk management planning, aggregate reporting, and regulatory submissions. This extensive experience positions us to deliver high-quality, client-centric solutions tailored to meet the unique challenges of the industry.
Which PV Services do you provide?
PharmExpert provides all of the services (En-to-End) available in the drug safety field.
Industry Insights: Global Pharmacovigilance Trends
The pharmacovigilance landscape is evolving rapidly, driven by advancements in technology and stricter regulatory standards. Artificial intelligence and machine learning are revolutionizing signal detection and data analysis, enabling faster identification of potential safety concerns. In emerging markets like CIS and EAEU, regulatory requirements are increasingly rigorous, emphasizing localized expertise and robust compliance strategies.
Additionally, real-world evidence (RWE) is playing a crucial role in improving post-market surveillance and informed decision-making. Global regulatory bodies are placing greater focus on patient-centric approaches, ensuring that drug safety monitoring aligns with public health priorities. PharmExpert keeps pace with these trends by integrating innovative tools and methodologies to deliver comprehensive international pharmacovigilance solutions. Our services are designed to meet the complexities of global regulations while safeguarding patient health and supporting your products’ success across international markets.
