Pharmacovigilance
Regulatory Compliance at the Forefront of Patient Safety
Qualified Pharmacovigilance Partner of Choice
Industry-leading experience and innovation
UBC, a leader in pharmacovigilance, combines deep clinical expertise with innovative technologies to enable biopharmaceutical industries to comply with global and local pharmacovigilance regulations across the product lifecycle, from initial clinical development to post-marketing surveillance.
Led by a team of pharmacovigilance experts, we have a deep understanding of the complex and rapidly evolving safety landscape and regulations. We are supported by an unmatched technology suite and operate on the principle that patient safety is a critical industry responsibility.
* From 2018 to Q2 2023
Pharmacovigilance Difference
Full-Service Outsourcing
Pharmacovigilance is vital for drug development and establishment of a product’s benefit-risk profile, and choosing the right partner is critical for success. UBC enables our customers to identify and manage potential risks associated with their products, maintain patient safety, and ensure high regulatory compliance throughout the drug development and commercialization process.
Technology
UBC provides purpose-built software solutions to drive efficiency, accuracy, and quality of the PV program through the automation of critical PV business processes including real time signal detection and management, literature review, safety case processing and reporting.
Collaboration
UBC partners with customers to ensure services align with business objectives and regulatory requirements necessary to deliver a robust, compliant PV program. Through collaboration, participation, and transparency, supported by an established governance model, we serve as an extension of our sponsors PV team.
Customization
UBC offers flexible PV solutions to address the sponsors unique needs and program requirements.
Global Reach
Partnering with sponsors globally, UBC has a thorough understanding of the global and regional PV regulatory landscape. Our PV Process Excellence Team, comprised of safety regulatory intelligence experts, continually evaluates regulatory information to ensure we are current on local PV requirements for all countries of interest.
Pharmacovigilance Services
Full-Service Outsourcing
Comprehensive, end-to-end service model enabling sponsors to have high-level oversight of their program while UBC holistically delivers against all facets of the PV program. UBC services include safety database configuration and maintenance, case processing from intake through regulatory submissions, case exchange with partners/affiliates, safety writing, signal detection, global and/or providing local literature screening, and safety regulatory intelligence. European post-marketing activities include serving as a Qualified Person for Pharmacovigilance (QPPV), establishing a Pharmacovigilance System Master File (PSMF), handling Eudravigilance registration, as well as local QPPVs / National Contact Persons for the EEA countries, UK, and Switzerland.
Safety Case Processing & Reporting
Experienced team of healthcare professionals with a deep understanding of the regulatory reporting requirements and nuances of the product safety profile, underpinned by technology-enabled case processing services, to support clinical trials, post-marketing studies, and spontaneous reporting.
Literature Review
Global and local literature screening, review, and tracking, leveraging a validated tool informed by literature review requirements, to identify potentially relevant safety information and safety reports.
Safety Writing
Proficient assessment of safety data and preparation and delivery of aggregate safety reports including Periodic Adverse Drug Experience Reports (PADERs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Safety Update Reports (DSURs).
Learn More About UBC's Pharmacovigilance Services
Interested in learning more about how UBC’s pharmacovigilance services can help you make more informed decisions earlier and meet regulatory requirements?
