Adverse Event Reporting: As regulatory service providers compile, document, and report AEs and other safety-related information to regulatory authorities according to their specific requirements. This encompasses serious adverse events (SAEs), adverse drug reactions (ADRs), and unexpected adverse events. Working with Analysis and Reporting: They analyze the incoming case safety reports and make necessary changes in ICSR and also generate periodic aggregate safety reports of the cases. Signal detection and management: Identification of potential safety signals through data analysis and signal detection activities This covers signal evaluation, validation, prioritization, and recommending additional actions (e.g., regulatory submissions, risk minimization measures). Risk Management Plans (RMPs): Development, implementation, and maintenance of Risk Management Plans (RMPs) as mandated by regulatory authorities. This includes the evaluation and minimization of risks related to the use of medicinal products throughout their lifecycle. Aggregate Reporting: Generating and writing periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate safety reports for submission to regulatory authorities. Post-market safety signal detection:Literature surveillance: Monitoring scientific literature and other data sources for new safety information relevant to marketed products. This allows for the detection of potential safety issues, which would enable modifications of the risk management plan. Regulatory Intelligence: Staying up-to-date with evolving pharmacovigilance regulations, guidelines, and best practices across the globe. Delivering regulatory updates and guidance compliant to changing regulatory needs. Quality Management : Systems to ensure that the quality of the pharmacovigilance activities is maintained. This can involve internal audits as well as compliance with standard operating procedures (SOPs) and regulatory requirements.

PHARMACOVIGILANCE - PharmReg Neoteric

Pharmacovigilance, the process of detecting, assessing, understanding, and preventing adverse effects or any other drug-related concern, is an integral part of pharmaceutical companies’ regulations to ensure patient safety and uphold a positive benefit-risk profile for their portfolio.
PharmReg Neoteric offers effective pharmacovigilance (PV) services that allow post-marketing safety practices around the lifecycle of the product to ensure safety. Examples of these services include adverse event reporting, ensuring compliance with regulations, and ongoing surveillance of product safety throughout development and post-market.

Variability in legislation as well as variability in healthcare infrastructure in different sites complicate the picture of the global pharmacovigilance (PV) trends and post-marketing safety requirements. There are several major challenges in achieving global harmonisation of pharmacovigilance compliance. Our team not only meets but exceeds international standards by delivering end-to-end pharmacovigilance solutions tailored specifically to clients, united in one common goal; safeguarding the welfare of patients globally. Highlights of Pharmacovigilance services provided by us:

Services Include

Adverse Event Reporting: As regulatory service providers compile, document, and report AEs and other safety-related information to regulatory authorities according to their specific requirements. This encompasses serious adverse events (SAEs), adverse drug reactions (ADRs), and unexpected adverse events.
Working with Analysis and Reporting: They analyze the incoming case safety reports and make necessary changes in ICSR and also generate periodic aggregate safety reports of the cases.
Signal detection and management: Identification of potential safety signals through data analysis and signal detection activities This covers signal evaluation, validation, prioritization, and recommending additional actions (e.g., regulatory submissions, risk minimization measures).
Risk Management Plans (RMPs): Development, implementation, and maintenance of Risk Management Plans (RMPs) as mandated by regulatory authorities. This includes the evaluation and minimization of risks related to the use of medicinal products throughout their lifecycle.
Aggregate Reporting: Generating and writing periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate safety reports for submission to regulatory authorities.
Post-market safety signal detection:Literature surveillance: Monitoring scientific literature and other data sources for new safety information relevant to marketed products. This allows for the detection of potential safety issues, which would enable modifications of the risk management plan.
Regulatory Intelligence: Staying up-to-date with evolving pharmacovigilance regulations, guidelines, and best practices across the globe. Delivering regulatory updates and guidance compliant to changing regulatory needs.
Quality Management: Systems to ensure that the quality of the pharmacovigilance activities is maintained. This can involve internal audits as well as compliance with standard operating procedures (SOPs) and regulatory requirements.