Pharmacovigilance/Drug Safety
Pharmacovigilance/Drug Safety
At GRC, we prioritize patient safety through our pharmacovigilance services, which monitor, assess, and prevent adverse drug reactions (ADRs). Our team ensures compliance with ICH, FDA, EMA, and local regulatory guidelines, adhering to global standards and industry best practices. We deliver superior drug safety across all stages of the product lifecycle.
Pharmacovigilance System Master File (PSMF)
GRC offers Pharmacovigilance System Master File (PSMF) services to ensure compliance with Good Pharmacovigilance Practice (GVP) in Arab countries and international regulations. These services include establishing a pharmacovigilance system, documenting Standard Operating Procedures (SOPs), ensuring regulatory compliance and audit readiness, and supporting regulatory inquiries. With GRC's expertise, pharmaceutical companies can maintain a compliant pharmacovigilance system that ensures patient safety and regulatory approval.
Qualified Person for Pharmacovigilance (QPPV)
GRC provides highly trained and experienced Qualified Person for Pharmacovigilance (QPPV) services, offering comprehensive 24/7 oversight of pharmacovigilance activities. Our QPPV services encompass managing Adverse Drug Reaction (ADR) reporting, maintaining the Pharmacovigilance System Master File (PSMF), serving as the primary regulatory contact for drug safety, and overseeing Risk Management Plans (RMPs). GRC’s dedicated QPPV support enables clients to achieve full regulatory compliance and adopt a proactive approach to patient safety and drug monitoring.
Individual Case Safety Report (ICSR)
GRC offers complete pharmacovigilance services, including ICSR management, signal detection & validation, and regulatory compliance. Our team performs risk-benefit assessments, evaluates drug safety profiles, identifies safety concerns, and recommends appropriate actions. GRC’s approach to ICSR reporting ensures accurate and timely submission of safety data, aiding pharmaceutical companies in maintaining global safety standards and compliance.
Pharmacovigilance (PV) Audits
GRC provides extensive pharmacovigilance (PV) audit services to assist pharmaceutical companies in maintaining compliance and preparing for regulatory inspections. Our PV Audit Services Include: Pre-Inspection Audits: Identifying potential gaps and ensuring preparedness for regulatory reviews. Handling Critical Findings: Addressing and mitigating compliance risks efficiently. Compliance Monitoring & Documentation: Ensuring adherence to global PV regulations through meticulous monitoring and record-keeping. With GRC’s expert PV audit services, clients can navigate regulatory inspections with confidence and uphold the highest standards of pharmacovigilance compliance.
Risk Management Plan (RMP)
GRC provides comprehensive RMP services to identify, characterize, and mitigate risks associated with medicinal products. Our team is proficient in creating detailed risk management plans, ensuring alignment with regulatory guidelines, and facilitating smooth submission processes. With our RMP services, companies can effectively manage product risks and enhance patient safety.
Periodic Benefit-Risk Evaluation Report (PBRER)
GRC offers expert PBRER services to evaluate the benefit-risk profile of medicinal products. We handle data collection, risk-benefit assessment, regulatory compliance, and report submission. GRC assists companies in managing safety concerns and remaining compliant.
Pharmacovigilance (PV) Database
GRC provides a validated, E2B-compliant PV database for clinical trials and post-marketing surveillance. Our services include ICSR management, ADR data handling, and expert MedDRA coding to ensure regulatory compliance and data accuracy.
Data Processing in Pharmacovigilance
GRC offers comprehensive data management services designed for precise safety data collection, tracking, and analysis. Our services encompass ICSR processing, signal tracking, and literature review, ensuring proactive risk management and adherence to regulatory compliance standards.
Post-Authorization Safety Studies (PASS)
Post-Authorization Safety Studies (PASS) examine the safety of approved drugs in real-world settings, identifying and managing risks. GRC provides customized study designs, expert clinical execution, and an extensive investigator network. Our PASS solutions ensure compliance, risk management, and patient safety.
Safety Communication
GRC develops, prepares, and submits safety communication materials according to regulatory requirements. Our services include DHPC development and submissions to Competent Authorities. Companies can leverage GRC's expertise to enhance transparency, manage risks, and ensure patient safety. We develop comprehensive study documentation to outline all steps of the data management process, including specific procedures such as the Data Management Plan (DMP), Data Validation Plan (DVP), validation checks specifications, SAE reconciliation, and medical data coding.