Safety Regulatory

Intelligence in

Pharmacovigilance

X Pharma Plus empowers pharmacovigilance operations with comprehensive Regulatory Intelligence (RI), providing global insights, region-specific guidance, and the latest updates from health authorities. Our services enable seamless compliance, robust safety monitoring, and data-driven decision-making throughout the drug lifecycle.

Safety Regulatory Intelligence in
Pharmacovigilance – Overview

Pharmaceutical organizations face challenges in keeping PV practices compliant due to evolving regulations, diverse regulatory processes, and language barriers. X Pharma Plus offers state-of-the-art PV Regulatory Intelligence services to help organizations stay abreast of global regulatory requirements and changes.

Our approach includes:

  • AI: AI-driven regulatory advisor for comprehensive PV regulation research worldwide, including non-English sources
  • RI surveillance: Combines technology and expertise to monitor regulatory changes in markets
  • RI coverage: Tracks regulatory organizations, trade associations, and product types covering ADR reporting, drug interactions, RMPs, safety monitoring, and more

Safety Regulatory Intelligence in
Pharmacovigilance
 – Services

“Continuous monitoring and evaluation of global safety regulations and guidelines to ensure compliance and proactive adaptation of pharmacovigilance processes.”

  • Cloud-based Regulatory Intelligence platform providing global PV regulatory updates
  • Country/region-specific PV consulting for drugs, devices, and biologics
  • Customized newsletters on PV regulatory updates tailored to client markets and products
  • Cross-country comparisons for PV requirements including ICSRs, periodic reports, PASS, non-interventional studies, inspections, PSMF, QPPV, RMPs, and signal management
  • Ensure global PV compliance and proactively mitigate risks
  • Enable timely detection and assessment of potential safety issues
  • Optimize drug safety and support the development of safer medicines
  • Seamlessly adapt PV strategies to product portfolio or business changes
  • Facilitate strategic decision-making with in-depth regulatory analysis
  • Gain competitive advantage through regulatory insights and best practices
  • Access bespoke solutions, expert guidance, and continuous support

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