Well trained Qualified Person for Pharmacovigilance (QPPV) and/ or his/her deputy is available round the clock, 7 days a week
Individual Case Safety Report (ICSR)
- Reporting ICSR data in the software system to Health Authorities.
- Detection, validation, analysis, and assessment of possible signals.
- Reporting of detected signals to Health Authorities within defined timelines.
- Risk-benefit assessment of the product to predict any changes in its safety profile.
- Pre-inspection audits to make sure your system is fully compliant with the latest regulatory requirements.
- Dealing with critical findings.
- Monitoring and documenting the compliance of case-reporting to regulatory authorities.
Risk Management Plan (RMP)
- Preparing Risk Management Plan.
- Medicinal Product’s safety concerns.
- Pharmacovigilance Plan designing to study Medicinal Product’s safety concerns.
- Risk Minimization Measures (RMMs).
- Risk factors for developing Adverse Drug Reactions (ADRs).
- Provide advice on responses to regulatory enquiries.
Pharmacovigilance System Master File (PSMF)
The core of the pharmacovigilance activities and involves all pertaining Standard Operating Procedures (SOPs) according to Good Pharmacovigilance Practice (GVP) in Arab countries.
GRC provides the following services:
- Establishment of a qualified Pharmacovigilance system which is tailored to the company’s resources and product registration status.
- Assistance with response to regulatory inquiries.
Periodic Benefit-Risk Evaluation Report-(PBRER):
The PBRER contains an evaluation of new information relevant to the Medicinal Product that became available to the Marketing Authorization Holder (MAH) during the reporting interval, in the context of cumulative information.
- PV database is recommended to support Individual Case Study Report (ICSR) analyses, reporting and archiving.
- Providing clients with access to a validated E2B-compliant database which is a flexible, efficient, and cost-effective way to centralize all your safety data.
- Management of Pharmacovigilance Data/Adverse Drug Reactions (ADRs), during clinical trials and Post-Marketing Surveillance Studies (PMSS).
- MedDRA coding with expert personnel who are well trained for MedDRA coding.
- Processing safety data (ICSRs) and signals.
- Tracking, assessing, and monitoring signals to detect possible changes in the safety profile of the product.
- International and Local Literature review for identification of published Adverse Events (AEs) or safety concerns.