PHARMACOVIGILANCE SERVICES
Inpharmatis ensures the reliability and efficiency of the pharmacovigilance system, including pharmacovigilance system master file (PSMF) creation, case processing, reporting, literature reviews, and management of pharmacovigilance lifestyle processes in Europe, CIS and EAEU: Uzbekistan, Kazakhstan, Russia, Belarus, Kyrgyzstan, Moldova, Armenia, Georgia, Tajikistan, Turkmenistan, Ukraine, Azerbaijan, Mongolia, Latvia, and others, in accordance with good pharmacovigilance practice (GVP).
Full Scope of Pharmacovigilance Services
Authorised Persons
(QPPV, LPPV)
PV System Creation and Management
Auditing and Inspection support
Pharmacovigilance Trainings
PSUR, RMP Reports Preparation
Monitoring and Signal Management
Monitoring of Local Medical Literature
Medical Information (MI) Support
Entrust Your pharmacovigilance concerns to the experienced hands of Inpharmatis Team. Whether You need an urgent solution for an unexpected problem or are seeking to outsource entire pharmacovigilance processes – our knowledgeable consultants will be there for You.
Proven Pharmacovigilance Experience
of proven experience operating in the EU, CIS and EAEU
the first pharmacovigilance system in the Baltic Countries
full-time employees working in the same quality system according to the international standards
a software solution for pharmacovigilance PRUDENTA to monitor side effects in the local medical literature
team proficient in English and the native language of the territory in scope
fulfilling the requirements of EU, CIS and EAEU – integrating all marketing countries into our global PV system
• Qualified Person for Pharmacovigilance (QPPV)
• Local Person for Pharmacovigilance (LPPV)
- Full coverage of EU, CIS, EAEU, Mongolia
- Availability 24/7
- Monitoring of scientific medical literature
- Expert clinical assessment
- Medical translation
- Support with preparation of aggregate reports
- Monitoring global and local PV legislation
- Interaction with local regulatory authorities
• Pharmacovigilance Quality System
- Writing and Implementing Standard Operating Procedures (SOPs)
• Pharmacovigilance System Master File (PSMF)
- Development and Maintenance
• Risk Management System
- Implementation
- Preparation and Submission of a Risk Management Plan (RMP)
• Critical Pharmacovigilance Processes
- Support Provision
• Pre-audits
- Preparation for Compliance with Good Pharmacovigilance Practice
• Audits
- GAP-analysis of the Pharmacovigilance System
- Development & Implementation of Corrective and Preventive Measures (CAPA)
• Regulatory Inspections
- Preparation
• Consulting Support
- Entire Process Chain
• Trainings for all employees
• Individual training of employees on certain issues related to pharmacovigilance
• Trainings with full coverage of pharmacovigilance services
- Pharmacovigilance system development
- Literature monitoring
- ICSR management
- Safety signal management
- Quality management system organization
• Individual Reports of Adverse Reactions
- Collection, translation, quality control
- Classification, clinical assessment, accounting
- Submission to local regulatory authorities
• Signal Management
• Database of Adverse Reactions
• Periodic Safety Reports Preparation
- Product Safety Update Reports (PSURs)
- Risk Management Reports (RMPs)
• Update of Drug Safety Information in SmPC
• Writing Clinical Reviews on Drug Safety Issues
• Experienced MI personnel
• MI enquiry management
• Timely, accurate and consistent responses
• Handling of standard and non-standard questions/requests
• Handling of adverse events and product quality complaints
• Integrated approach to our customers’ needs
You want to optimise patient safety solutions by guaranteed highly qualified support, deadline compliance, and project control? If so, get in touch with us!