End-to-End Pharmacovigilance Services
Pharmacovigilance System Development & Maintenance
We design, implement, and continuously optimize robust pharmacovigilance systems tailored to your operations. Our systems are fully compliant with local guidelines and harmonized with international regulatory standards. From small-scale systems to enterprise-wide PV frameworks, we ensure your pharmacovigilance function is inspection-ready and future-proof.
Case Management & Adverse Event (AE) Reporting
IntraHub streamlines your AE reporting processes to improve efficiency, accuracy, and compliance. We manage the full lifecycle of Individual Case Safety Reports (ICSRs) from collection and data entry to medical review and submission to regulatory authorities. We help reduce underreporting, improve data quality, and facilitate timely submissions.
Regulatory Documentation Preparation & Review
Our team expertly prepares and reviews all essential pharmacovigilance documentation, including:
- Pharmacovigilance System Master File (PSMF)
- Periodic Safety Update Reports (PSURs)
- Risk Management Plans (RMPs)
- Aggregate reports and other local requirements
We ensure your documentation meets both local and global regulatory expectations.
Audit & Inspection Preparation
With increasing regulatory scrutiny, being inspection-ready is critical. We conduct comprehensive system audits, gap analyses, and mock inspections to assess your readiness. Our team helps you correct deficiencies, implement corrective and preventive actions (CAPAs), and confidently face regulatory audits.
Pharmacovigilance Consulting & Advisory
Gain access to specialized consulting services designed to improve your overall pharmacovigilance operations. We provide strategic insights, ongoing support, and compliance monitoring to help you:
- Navigate complex regulatory environments
- Optimize PV processes and workflows
- Implement automation where applicable
- Stay ahead of regulatory changes.
Our Approach
At IntraHub, we combine local insight, global best practices, and technology-driven methods to deliver results that matter:
- Reduce your regulatory risk
- Enhance operational efficiency
- Strengthen patient safety
- Improve your market competitiveness
We take time to understand your products, markets, and challenges, crafting tailor-made solutions rather than generic templates.
Who We Serve
- Pharmaceutical Companies
- Contract Research Organizations (CROs)
- Biotechnology Companies
- Healthcare Institutions
- Medical Device Companies
Why Choose IntraHub?
✔ Proven expertise in Nigerian and African pharmacovigilance regulations
✔ Global-standard compliance
✔ End-to-end pharmacovigilance support
✔ Dedicated, highly qualified pharmacovigilance professionals
✔ Technology-backed services for improved efficiency
Your commitment to drug safety deserves a trusted partner. IntraHub is here to help you protect patients, meet regulatory expectations, and thrive in the market.