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Welcome to our exceptional pharmacovigilance services, where we are committed to ensuring the safety and efficacy of medications throughout their lifecycle. With a focus on systematic data collection, assessment, and analysis, we play a crucial role in identifying and managing potential risks associated with drugs. Trust us to provide comprehensive drug safety monitoring solutions to safeguard patient health.

Get in touch at

info@baupharma.com

Pharmacovigilance services

Safeguarding Patient Health through Comprehensive Drug Safety Monitoring

Our pharmacovigilance services provide comprehensive drug safety monitoring solutions to safeguard patient health. With a focus on systematic data collection, assessment, and analysis, we ensure the safety and efficacy of medications throughout their lifecycle. Our expertise includes adverse event reporting, data analysis and signal detection, regulatory compliance, risk assessment and management, effective communication, and a patient safety focus. Partner with us to proactively identify and manage potential risks, contributing to the overall well-being and safety of patients.

Pharmacovigilance services

● PSMF
● Creation
● Review/Update
● EU QPPV
● Local QPPVs
● Local Safety Officers
● Drug Safety Officers
● Literature search
● Global
● Local
● Data Management
● PV Database
● ICSR
● XEVMPD
● IDMP
● Audits
● Inspections Support
● Assistance in Critical Findings
● CAPA preparation
● Pharmacovigilance Training
● Pharmacovigilance Intelligence

When you choose our pharmacovigilance services, you can expect a dedicated team committed to upholding the highest standards of drug safety monitoring. Partner with us to proactively identify and manage potential risks, contributing to the overall well-being and safety of patients. Contact us today to discuss your pharmacovigilance needs and let us help you safeguard patient health.

Why us

Expertise and Experience

Our team of pharmacovigilance professionals brings extensive expertise and experience in the field. With a deep understanding of pharmacovigilance regulations, best practices, and industry standards, we are well-equipped to handle the complexities of drug safety monitoring.

Adverse Event Reporting

We facilitate the reporting and documentation of adverse events associated with medication use. Our streamlined reporting processes ensure that healthcare professionals, patients, and other stakeholders can easily report any unexpected or harmful reactions, allowing for timely identification and assessment of potential safety concerns.

Data Analysis and Signal Detection

Our skilled pharmacovigilance experts employ advanced data analysis techniques and data mining tools to detect patterns and signals that may indicate previously unknown risks associated with specific drugs. By analysing comprehensive data from various sources, we proactively identify potential safety concerns.

Regulatory Compliance

We have a thorough understanding of pharmacovigilance regulations and guidelines. Our services ensure compliance with regulatory reporting requirements, including timely and accurate submission of safety reports to regulatory authorities. We assist in preparing risk management plans and support audits and inspections to ensure regulatory compliance.

Risk Assessment and Management

Our pharmacovigilance services include comprehensive risk assessment and management. We evaluate the risks associated with medications by analysing factors such as the severity and frequency of adverse events. Based on these assessments, we develop risk management plans to minimize potential harm, including additional safety measures and educational interventions.

Effective Communication

We understand the importance of clear and effective communication in pharmacovigilance. Our services include the preparation of safety narratives, periodic safety update reports (PSURs), and other documents to ensure accurate and timely communication of safety information to regulatory authorities, healthcare professionals, and the public.

Patient Safety Focus

Patient safety is at the heart of our pharmacovigilance services. By monitoring and managing drug safety throughout the lifecycle, we contribute to ensuring that patients receive safe and effective treatments. Our efforts aim to minimize the risks associated with medications and promote their safe and appropriate use.

Get In Touch

We value your input and always appreciate feedback. Your suggestions and comments help us improve our services, ensuring that we consistently meet your needs and exceed your expectations.

Thank you we will get back to you shortly!

MO - FR 9:00 am - 5:00 pm

+ 420 774 557 550

info@baupharma.com

Czech Republic,
Nile House, Karolinská 654/2, Karlín, 186 00, Prague