Adverse Event Reporting: Regulatory service providers manage the collection, documentation, and reporting of adverse events (AEs) and other safety-related information to regulatory authorities as per their requirements. This includes serious adverse events (SAEs), adverse drug reactions (ADRs), and unexpected adverse events. Case Processing: They handle the processing of individual case safety reports (ICSRs), which involves data entry, assessment of seriousness and causality, coding of medical terms (MedDRA coding), and narrative writing. Signal Detection and Management: Identifying potential safety signals through data analysis and signal detection activities. This includes signal evaluation, validation, prioritization, and recommendation of further actions (e.g., regulatory submissions, risk minimization measures). Risk Management Plans (RMPs): Development, implementation, and maintenance of risk management plans as required by regulatory authorities. This involves assessing and mitigating risks associated with the use of medicinal products throughout their lifecycle. Aggregate Reporting: Preparation and submission of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate safety reports to regulatory authorities. Literature Surveillance: Monitoring scientific literature and other data sources for new safety information relevant to marketed products. This helps in identifying potential safety concerns and updating risk management strategies accordingly. Regulatory Intelligence: Keeping abreast of changes in pharmacovigilance regulations, guidelines, and best practices globally. Providing regulatory updates and guidance to ensure compliance with evolving regulatory requirements. Quality Management: Implementing quality assurance and quality control measures to ensure the accuracy, completeness, and timeliness of pharmacovigilance activities. This includes conducting internal audits and ensuring compliance with standard operating procedures (SOPs) and regulatory requirements.

PHARMACOVIGILANCE - PharmReg Neoteric

Pharmacovigilance (PV) services provided by PharmReg Neoteric are crucial for ensuring the safety of pharmaceutical products throughout their lifecycle. Pharmacovigilance encompasses the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

Pharmacovigilance services provided by PharmReg Neoteric are essential for pharmaceutical companies to meet regulatory obligations, ensure patient safety, and maintain the benefit-risk profile of their products. These services encompass a wide range of activities from adverse event reporting to regulatory compliance and continuous monitoring of product safety throughout its lifecycle.

Diverse regulatory frameworks and disparities in healthcare infrastructure across different locations make it difficult to navigate global pharmacovigilance (PV) trends and post-marketing safety requirements. Ensuring global pharmacovigilance compliance presents several significant issues.By providing a full range of pharmacovigilance services, our team strives to not only meet but beyond international standards, helping to achieve the shared objective of preserving patient welfare worldwide. Here are some key aspects of pharmacovigilance services offered by us:

Services Include

Adverse Event Reporting: Regulatory service providers manage the collection, documentation, and reporting of adverse events (AEs) and other safety-related information to regulatory authorities as per their requirements. This includes serious adverse events (SAEs), adverse drug reactions (ADRs), and unexpected adverse events.
Case Processing: They handle the processing of individual case safety reports (ICSRs), which involves data entry, assessment of seriousness and causality, coding of medical terms (MedDRA coding), and narrative writing.
Signal Detection and Management: Identifying potential safety signals through data analysis and signal detection activities. This includes signal evaluation, validation, prioritization, and recommendation of further actions (e.g., regulatory submissions, risk minimization measures).
Risk Management Plans (RMPs): Development, implementation, and maintenance of risk management plans as required by regulatory authorities. This involves assessing and mitigating risks associated with the use of medicinal products throughout their lifecycle.
Aggregate Reporting: Preparation and submission of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs), and other aggregate safety reports to regulatory authorities.
Literature Surveillance: Monitoring scientific literature and other data sources for new safety information relevant to marketed products. This helps in identifying potential safety concerns and updating risk management strategies accordingly.
Regulatory Intelligence: Keeping abreast of changes in pharmacovigilance regulations, guidelines, and best practices globally. Providing regulatory updates and guidance to ensure compliance with evolving regulatory requirements.
Quality Management: Implementing quality assurance and quality control measures to ensure the accuracy, completeness, and timeliness of pharmacovigilance activities. This includes conducting internal audits and ensuring compliance with standard operating procedures (SOPs) and regulatory requirements.