Pharmacovigilance Services
End-to-end safety operations support built for compliance, quality, and inspection readiness
Inspire Pharma Consultancy provides end-to-end pharmacovigilance support to help organisations stay compliant and protect patient safety across all product stages.
How We Support You
Safety Reports Management
Efficient management of safety reports to ensure timely and accurate reporting in accordance with industry standards and regulatory requirements.
Collection of Individual Case Safety Reports (ICSRs)
Literature Monitoring
Continuous monitoring of local and global scientific literature to identify and evaluate safety information relevant to your products as per regulatory requirements.
We provide local and global literature screening services, including building a literature monitoring plan for each product—ideal for companies seeking to outsource literature monitoring due to constrained internal resources, limited technical or operational capacity, or absence of access to comprehensive local and global scientific resources and subscriptions.
This service helps increase team capacity and ensures that literature monitoring is completed to a high standard. We ensure compliance with regulatory requirements for continuous local and global data surveillance.
Clinical Trials, Patient Support Programs (PSPs), Named Patient Programs (NPPs)
We support companies running Patient Support Programs (PSPs), Named Patient Programs (NPPs), or Clinical Trials by managing safety reporting requirements and developing Clinical Trials Safety Management Plans.
We assist companies running Patient Support Programs (PSPs), Named Patient Programs (NPPs), or Clinical Trials by managing safety reporting requirements.
Risk Management Systems (RMSs), Risk Management Plans (RMPs), and Risk Minimisation Measures (RMMs) Development
We assist companies in establishing and maintaining robust Risk Management Systems (RMS), including the development and management of Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs), in line with regulatory authority requirements.
We support companies in establishing, developing, and maintaining comprehensive Risk Management Systems (RMS), including the development and continuous improvement of Risk Management Plans (RMPs) and Risk Minimisation Measures (RMMs), in alignment with regulatory authority requirements and global standards.
Our experts ensure that safety concerns are clearly identified, characterized, and effectively managed throughout the product lifecycle.
Preparing and submitting Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs)
We help companies streamline PSUR and DSUR preparation, ensuring high-quality, compliant, and timely reporting. Inspire Pharma Consultancy can equip your staff with the necessary knowledge and skills to prepare and maintain PSURs/DSURs in accordance with regulatory authority requirements.
We support companies in preparing and submitting Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs) in compliance with regulatory authority requirements, ensuring timely submission according to regulatory timelines.
SOPs, WIs, and SDEAs Review and Development
We help companies streamline documentation processes, ensuring that SOPs and WIs are clear, compliant, and aligned with regulatory requirements. Inspire Pharma Consultancy also equips your team with the knowledge and skills to effectively implement and maintain these procedures.
We help companies establish, review, and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure compliance with regulatory authority requirements and industry best practices.
Safety Data Exchange Agreements (SDEAs) Review and Development
Inspire Pharma Consultancy helps companies establish and maintain effective, compliant, and structured SDEAs, ensuring timely exchange of safety data, regulatory compliance, and smooth integration with global pharmacovigilance systems.
Safety Data Exchange Agreements (SDEAs) are formal agreements established when a Marketing Authorisation Holder (MAH) has contractual arrangements with a person or organisation. These agreements ensure that the MAH can comply with the submission of valid Individual Case Safety Reports (ICSRs) within the required regulatory timelines.
SDEAs define the processes for exchanging safety information, specify timelines and responsibilities for regulatory submissions, and are structured to avoid duplicate reporting to competent authorities.
Audit and Inspection Readiness
In line with GVP guidance, marketing authorisation holders (MAHs) must perform regular risk-based audits of their pharmacovigilance systems. Inspire Pharma Consultancy (IPC) helps organisations meet this requirement through structured, risk-based audit planning and continuous improvement approaches—ensuring robust quality systems, effective CAPA management, and sustained regulatory compliance.
Pharmacovigilance audits and regulatory inspections are essential for demonstrating compliance with global safety and quality standards. At Inspire Pharma Consultancy (IPC), we help organisations strengthen their audit and inspection preparedness through proactive evaluation, strategic planning, and expert execution.
In addition to conducting mock audits and readiness assessments, IPC can perform full audits on behalf of marketing authorisation holders to evaluate the compliance of their affiliates, partners, or distributors. Our comprehensive approach ensures alignment with Good Pharmacovigilance Practices (GVP), ICH guidelines, and local regulatory requirements.
Safety Signal Management
Inspire Pharma Consultancy delivers the full spectrum of signal management activities including detection, validation, analysis, prioritisation, assessment, and management of emerging safety issues to help organisations maintain regulatory compliance, protect patient safety, and proactively manage evolving safety risks
Inspire Pharma Consultancy supports companies in establishing and maintaining an effective and compliant safety signal management process., ensuring timely detection, assessment, and regulatory-compliant reporting of safety signals and emerging safety issues.
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