Local Affiliate Pharmacovigilance Services
We help companies navigate complex regional and local pharmacovigilance regulatory requirements to streamline expansion to new markets, facilitate growth in current markets, and gain workload flexibility without compromising quality.
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By leveraging our expert support to bridge the gap between global pharmacovigilance standards and local requirements, you can more easily address key challenges including:
- Regulatory Complexity: Manage diverse and evolving regulations across different regions, especially in the EU, where local safety requirements vary significantly
- Resource Limitations: Many Marketing Authorization Holders (MAHs) lack sufficient local safety resources, leading to potential risks in case reporting
- Monitoring Obligations: Companies must track local medical literature and submit individual case safety reports (ICSRs) to national databases, which can be resource-intensive
- High-Risk Therapies: Advanced medicinal therapies (ATMPs) incur higher safety management costs and obligations, complicating compliance further
With more than more than 1000 subject matter experts and native pharmacovigilance resources in 150 countries, we help companies harmonize pharmacovigilance activities and communications across regions. You can quickly scale with expert local staff to meet country-specific safety mandates, supporting growth objectives while reducing regulatory and revenue risk.
Our local affiliate pharmacovigilance customers range from biopharmaceutical companies launching their first product in a new market, to some of the largest life science companies with an established global presence seeking to optimize market growth.
These customers trust us to provide comprehensive, localized safety support when and where they need it across a range of services, such as the Qualified Person for Pharmacovigilance (QPPV) and specialized reporting mandated by many countries.
Our customer – a mid-sized biopharmaceutical company with a global presence and broad portfolio of marketed products and robust pipeline in multiple therapeutic areas – was looking for an experienced single global vendor to meet its extensive requirements for local affiliate pharmacovigilance support.
After reviewing multiple bids, the company chose PharmaLex as having the capabilities and expertise that best matched its requirements. Drawing on our extensive network of local PV professionals, we then rapidly fielded an 81-strong team of local PV staff to meet the identified capacity needs – including a complete crew of experienced Regional Leads.
The result? Today, the customer benefits from a streamlined and standardized approach to its local PV processes, driving significant improvements in cross-functional interaction, quality, compliance, efficiency, and cost control.
From the customer:
“Collaborating with PharmaLex is one of our greatest successes.”
“What we have achieved thus far is incredible…huge step toward harmonization of local PV processes with centralized oversight.”
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PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.