PHARMACOVIGILANCE SERVICES

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Inpharmatis provides a full scope of pharmacovigilance consulting services to support pharmaceutical companies worldwide
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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 in accordance with good pharmacovigilance practice (GVP).

Full Scope of Pharmacovigilance Services

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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. 

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Proven Pharmacovigilance Experience

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15+ years

of proven experience operating in the EU, CIS and EAEU

Established

the first pharmacovigilance system in the Baltic Countries

Experienced

full-time employees working in the same quality system according to the international standards

Developed

a software solution for pharmacovigilance PRUDENTA to monitor side effects in the local medical literature

Multilingual

team proficient in English and the native language of the territory in scope

Global PV Set Up

fulfilling the requirements of EU, CIS and EAEU – integrating all marketing countries into our global PV system

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Supporting Your Entire Pharmacovigilance Journey!
Certified Qualified Person for Pharmacovigilance

• 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 System Development

• 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

Advanced Pharmacovigilance Audits

• 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

Pharmacovigilance Professional Trainings

• 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

Safety Data Management

• 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

Medical Information (MI) Support

• 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

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You want to optimise patient safety solutions by guaranteed highly qualified support, deadline compliance, and project control? If so, get in touch with us!

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