Service Based Frequently Asked Questions (FAQs)

IntraHub Technologies Ltd. is a leading provider of pharmacovigilance and regulatory affairs solutions in Nigeria and across Africa. We specialize in delivering technology-driven solutions to enhance drug safety, ensure regulatory compliance, and empower healthcare professionals through expert training and innovative platforms.

We primarily serve pharmaceutical companies, biotechnology firms, healthcare institutions, clinical research organizations (CROs), and non-governmental organizations (NGOs) involved in drug safety and regulatory compliance.

Pharmacovigilance is critical for monitoring, assessing, and preventing adverse drug reactions (ADRs) to ensure patient safety, regulatory compliance, and public health. Effective pharmacovigilance protects pharmaceutical companies from regulatory penalties and enhances trust in their products.

We provide a comprehensive range of pharmacovigilance services, including:

• Adverse Drug Reaction (ADR) Reporting & Management: Capturing, assessing, and reporting adverse events.
• Pharmacovigilance System Development: Building compliant systems tailored to local and international regulations.
• Signal Detection & Risk Management: Identifying and managing safety risks using advanced analytics.
• Post-Marketing Surveillance: Ongoing monitoring of marketed products to identify safety concerns.
• Pharmacovigilance Audits & Inspection Readiness: Preparing for regulatory inspections and ensuring compliance.

QPPV (Qualified Person for Pharmacovigilance) Services: Providing expert oversight to meet pharmacovigilance regulatory obligations.

Our services comply with NAFDAC, PCN, MDCN, and international guidelines like ICH and WHO. We offer tailored solutions and ensure continuous updates to align with the latest regulations.

Yes. We perform systematic literature reviews to identify emerging safety signals and assess potential risks, ensuring timely detection and reporting to regulatory bodies.

Our regulatory affairs services include:

• Product Registration & Market Authorization: Assisting with product licensing and regulatory filings.
• Regulatory Submission & Compliance Support: Ensuring your documentation meets national and international standards.
• Trademark Registration: Supporting intellectual property protection for pharmaceutical products.
• Healthcare Advisory Services: Providing expert insights to navigate complex regulatory frameworks.

We prepare companies through comprehensive audits, mock inspections, and corrective action planning to ensure full compliance with regulatory requirements.

Our cloud-based pharmacovigilance database enables automated adverse event reporting, advanced analytics, and real-time monitoring. It supports multi-channel case intake and integrates with local and global regulatory platforms.

Our platform provides:

• ADR Case Management: Streamlined capture and reporting.
• Signal Detection & Analysis: Using AI-driven tools for early identification.
• Customizable Dashboards: Real-time insights and analytics.

Regulatory Reporting Integration: Direct submission to regulatory bodies.  

We offer specialized training for healthcare professionals, pharmaceutical companies, and regulatory staff covering:

• Fundamentals of Pharmacovigilance
• Regulatory Affair and Compliance
• Inspection Readiness & Audit Preparation
• Advanced Pharmacovigilance Data Management 
  

Yes, our programs provide certificates of completion and are aligned with global best practices in pharmacovigilance and regulatory affairs.   

Our client engagement process is simple and transparent:

1. Initial Consultation: We understand your business needs and regulatory requirements.
2. Customized Solution Design: Tailoring our services and technology to your unique needs.
3. Implementation: Seamless onboarding, system integration, and regulatory support.
4. Ongoing Support: Continuous monitoring, reporting, and expert guidance.

The timeline varies based on the complexity of your needs. On average, full implementation takes 4-8 weeks, including training and system setup.