Local PvOI Services.
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We provide qualified Pharmacovigilance Officer of India (PvOI) services to ensure your organization meets all CDSCO regulatory requirements and PvPI (Pharmacovigilance Programme of India) obligations. Our PvOI professionals serve as your designated point of contact for Indian regulators on all drug safety matters, providing seamless coordination between your global PV operations and local compliance needs.
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Our Local PvOI services encompass PSMF review and maintenance for the Indian market, PV compliance monitoring, safety reporting oversight, and regulatory coordination with CDSCO and PvPI authorities. We ensure that all Individual Case Safety Reports, aggregate reports, and signal management activities align with Indian regulatory timelines and requirements.
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We also supports organizations with inspection readiness preparation specific to CDSCO expectations, ensuring your documentation, processes, and personnel are prepared for regulatory scrutiny. Our experienced PvOI professionals integrate with your global PV framework while maintaining full compliance with local Indian pharmacovigilance regulations.
Quality Management System.
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We helps pharmaceutical and biotechnology companies establish, enhance, or scale their Pharmacovigilance Quality Management Systems (PV QMS) in alignment with EU GVP Module I, FDA guidance, and ICH Q10 quality principles. We support organizations in building structured, inspection-ready PV quality frameworks that ensure consistent compliance and operational governance.
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Our PV QMS services include development of organizational structures and role-specific job descriptions, creation of comprehensive SOPs and work instructions, establishment of quality policies and governance frameworks, and implementation of CAPA and deviation management systems designed for pharmacovigilance operations.
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PVCON also prepares Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) to ensure compliant safety data exchange with partners, licensees, and distributors. Whether you are a startup building your first PV system or an established company scaling operations, we deliver tailored QMS solutions that grow with your organization.
Regulatory Intelligence.
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Our regulatory intelligence services help organizations stay ahead of evolving global pharmacovigilance regulations, guidelines, and enforcement trends. We provide systematic monitoring of regulatory developments across major authorities including the EMA, FDA, MHRA, PMDA, TGA, and CDSCO to ensure your PV operations remain compliant with current requirements.
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Our regulatory intelligence framework goes beyond monitoring — we deliver actionable impact assessments that evaluate how new regulations, guideline revisions, and enforcement trends affect your specific PV operations. We develop practical implementation strategies that align your processes, documentation, and training with updated regulatory expectations.
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We also supports organizations with safety reporting alignment across jurisdictions, compliance benchmarking against industry standards, and advisory services that anticipate regulatory direction. Our proactive approach ensures your pharmacovigilance system evolves in step with the regulatory landscape, reducing compliance risk and strengthening your position during inspections.