Pharmacovigilance CROs: Safeguarding Public Health Amid Drug Shortages

As a premier pharmacovigilance CRO, we offer an array of pharmacovigilance services tailored to meet the specific needs of pharmaceutical companies across the globe. With our industry-leading expertise, we support the safety of investigational products through every phase of their development, providing robust pharmacovigilance consultancy that helps organizations maintain compliance and mitigate risk.

Our pharmacovigilance specialists understand the intricacies of drug safety, offering solutions that encompass the entire life cycle of a drug, from clinical development through post-market surveillance.

Navitas Life Sciences focuses on drug safety and pharmacovigilance with cutting-edge ICSR pharmacovigilance capabilities and centralized processes that ensure seamless data integration across multiple studies and geographies.

Addressing Drug Shortages with Pharmacovigilance Expertise

In the context of drug safety, managing drug shortages has become an increasingly pressing issue. As outlined by the FDA, drug shortages can arise from a variety of factors, including disruptions in manufacturing, quality issues, and unexpected surges in demand.

Here are the USFDA’s 7 key points about how the Center for Drug Evaluation and Research (CDER) manages drug shortages:

1. The Drug Shortage Staff (DSS) leads CDER's efforts in evaluating and managing drug shortages.
2. Drug companies must notify the FDA of manufacturing disruptions that could cause shortages.
3. DSS classifies a product as in shortage based on specific conditions.
4. CDER updates the Drug Shortage Database once a product is confirmed to be in shortage.
5. DSS coordinates all efforts to prevent and mitigate drug shortages.
6. Shortages can be reported by the public through a notification portal.
7. A shortage is resolved when manufacturers can meet national demand, and the market stabilizes.

Source: 7 Things to Know About Drug Shortage Management | FDA

Risk management plans (RMPs) provide a framework for identifying potential risks to the drug supply and implementing strategies to address them, ensuring that disruptions are minimized.

At Navitas Life Sciences, we understand the intricate connection between drug shortages and pharmacovigilance. Drug shortages can exacerbate risks related to patient safety, especially when it comes to critical therapies like antibiotics and cancer treatments. Our expertise in both drug safety and regulatory compliance enables us to support pharmaceutical companies in navigating these challenges, ensuring that patient safety is prioritized even in times of supply chain disruptions.

Article

How Do Drug Shortages Affect Pharmacovigilance?

September 17, 2024

Drug shortages can complicate pharmacovigilance efforts, stressing the importance of maintaining stringent safety measures even when access to medicines is limited. Learn more in our article here: How Do Drug Shortages Affect Pharmacovigilance?

Driving Innovation in Drug Safety with Customizable Solutions

At Navitas Life Sciences, our pharmacovigilance services are fully customizable and designed to scale with your needs, whether you require complete pharmacovigilance solutions or specific support. Our innovative approach utilizes advanced technology and automation to streamline safety reporting and case processing, enabling faster and more accurate pharmacovigilance operations. By employing a “follow-the-sun” service model, we enhance responsiveness while reducing delays, ensuring drug safety is never compromised.

End-to-End Services

Our end-to-end services include

• Clinical PV Project Management
• Full QPPV Services
• Safety Management Plans
• Safety Technology
• Clinical PV Technology and Automation
• Safety Reporting System Strategy
• Safety Review Committee and Safety Review Meetings
• Clinical Case Processing
• Case Medical Review and Assessment
• Safety Submissions
• Regulatory Intelligence
• Signal Management Services
• Medical Information Contact Center
• Literature Monitoring
• Aggregate Reporting
• PV Agreements

Whether you’re looking for a pharmacovigilance CRO to handle complex global trials or need a specialized consultancy to guide your team through regulatory complexities, our experienced team is ready to help. From safety reporting systems to safety review committees, we deliver comprehensive support to optimize your product's safety profile. With Navitas Life Sciences as your partner, your drug development journey will be backed by a team of specialists dedicated to delivering top-tier drug safety and pharmacovigilance services.

If you would like to learn more, our team of experts will be available at Booth 639 at the World Drug Safety Congress Americas taking place in Boston October 29 – 30 – we hope to see you there!

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