Ensuring patient safety and regulatory compliance is at the heart of every successful pharmaceutical operation. At Navatio Pharma, we provide comprehensive Pharmacovigilance (PV) system setup and maintenance services, helping pharmaceutical companies establish robust safety monitoring frameworks that align with global regulatory requirements.
Our Expertise in Pharmacovigilance System Setup
Setting up a compliant and efficient pharmacovigilance system requires in-depth knowledge of industry standards, regulations, and best practices. Our team of experts assists in
End-to-End PV System Implementation
From initial planning to full-scale operational deployment.
01
Risk-Based Approach
Developing tailored pharmacovigilance strategies based on product profiles and market requirements.
02
Regulatory Compliance
Ensuring adherence to international guidelines such as ICH, EMA (EudraVigilance), FDA, MHRA, and WHO.
03
Standard Operating Procedures (SOPs)
Drafting and implementing SOPs to maintain a structured and audit-ready PV system.
04
Qualified Person for Pharmacovigilance (QPPV) Support
Appointing and training responsible personnel for global PV compliance.
05
Safety Data Exchange Agreements (SDEAs)
Structuring agreements to manage safety data responsibilities with partners and affiliates.
06Ongoing Pharmacovigilance System Maintenance
A well-established PV system requires continuous monitoring, optimization, and compliance updates to keep up with evolving regulatory landscapes. Our maintenance services include
- Periodic Safety Updates – Reviewing, analyzing, and submitting Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), and Risk Management Plans (RMPs).
- Adverse Event Monitoring & Signal Detection – Utilizing advanced AI-driven tools to detect safety signals and trends efficiently.
- Case Processing & Management – End-to-end management of Individual Case Safety Reports (ICSRs) with high accuracy and timeliness.
- Audits & Inspections – Assisting with regulatory inspections, internal audits, and compliance gap assessments.
- Pharmacovigilance Database Maintenance – Ensuring seamless operation, validation, and upgrades for regulatory-compliant safety databases.
- Ongoing Training & Compliance Support – Conducting training sessions to keep teams updated on the latest PV regulations.
Why Choose Navatio Pharma?
At Navatio Pharma, we take a proactive and strategic approach to pharmacovigilance, ensuring drug safety, regulatory compliance, and operational excellence at every stage.