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Regulatory Intelligence in Pharmacovigilance
Pharma’s Global Regulatory Intelligence (GRI) empowers your pharmacovigilance endeavors with global insights, region-specific guidance, and the latest updates from health authorities. With Pharma, pharmaceutical organizations like yours can take advantage of the comprehensive intelligence that facilitates seamless compliance, robust safety monitoring, and data-driven decision-making throughout the drug lifecycle, keeping you abreast of all regulatory requirements and changes.
Regulatory Intelligence in Pharmacovigilance - Overview
Every aspect of the product lifecycle (ranging from development to post-market surveillance) in the pharmaceutical industry is governed by regulations. However, keeping up with the changes in the regulatory landscape across the globe, especially in the pharmacovigilance space, can be challenging because of varied reasons, including a diverse set of regulatory processes and languages. Pharma helps organizations keep their PV practices compliant with global regulations by offering state-of-the-art PV Regulatory Intelligence services.
Comprehensive Approach to Regulatory Intelligence in Pharmacovigilance
Pharmaās approach to Pharmacovigilance RI services is as follows:
- Pharma, an AI-driven regulatory advisor, helps users with comprehensive research on PV regulations across the globe (including those that come in non-English languages).
- A holistic RI surveillance system based on the synergy between cutting-edge technology and subject matter expertise, making it possible to effectively manage the ever-evolving regulatory landscape around pharmacovigilance in 150+ markets.
- Broad RI data coverage across 500+ regulatory organizations, 50+ trade associations, and 100+ product types to cover topics such as Adverse Drug Reaction Reporting/Safety Reporting, Drug Interactions and Contraindications, Risk Management Plan, and Safety and Performance Monitoring.
Regulatory Intelligence in Pharmacovigilance
- Expertise
- Advantages
- A cloud-based Regulatory Intelligence platform with advanced technology to provide comprehensive and global intelligence for all PV-related regulations in a user-friendly manner.
- Pharmacovigilance consulting services on regulations for individual countries/regions across product types (drugs, devices, or biologics).
- Periodic newsletters around PV regulatory updates, customized with a special focus on the markets and products of interest for clients.
- Foreign Safety Action Notification service based on the real-time monitoring of 200+ regulatory agencies with the help of intelli-bots
- Cross-country comparisons for various PV regulatory requirements, including:
- ICSR Management
- Periodic Reports
- Interventional Post-authorization Safety Studies
- Non-interventional Post-authorization Safety Studies
- Pharmacovigilance Inspections
- Pharmacovigilance System Master File
- Qualified Person for Pharmacovigilance
- Risk Management Plans
- Signal Management
- Ensure global PV compliance and mitigate risks through proactive monitoring of evolving regulations
- Stay up to date on evolving PV requirements across 150+ markets around the globe
- Enable timely detection and assessment of potential safety issues
- Optimize drug safety and foster the development of safer medicines
- Seamlessly adapt PV strategies as product portfolios or business needs evolve
- Facilitate strategic decision-making with in-depth regulatory analysis and cross-country comparisons
- Gain a competitive edge through regulatory insights and best practices
- Get access to bespoke solutions, expert guidance, and continuous support
