Bharrgava Global
Pharmacovigilance
he FDA Group provides life science companies access to highly skilled consultants who can handle a wide range of pharmacovigilance projects and needs. Our consultants, many of whom are former FDA, are experts in the science and activities related to detecting, evaluating, understanding, and preventing adverse effects associated with pharmaceutical and medical device products. Teams work with us when they want to ensure the safety of their products throughout their lifecycle. We help you bring products to market and keep them there
Pharmacovigilance System Development and Maintenance:
Building and maintaining an effective pharmacovigilance system is critical for ensuring the safety of your products. Our services in this area include, but are not limited to:
Standard Operating Procedure (SOP) Development and Review: Creating and updating SOPs and working practices to support all PV activities within your organization.|
Safety Data Exchange Agreements: Authoring and maintaining agreements to ensure accurate and timely safety data exchange.
Company Core Datasheet (CCDS) Maintenance, development, and governance of labeling committees and management of safety variations and urgent safety restrictions.
Safety Database Management Consultancy support for safety database due diligence, set-up, validation, and data migration activities.
Global Safety Committee Activities: Management and support of safety committees to oversee safety signal management and risk minimization activities.
PV Quality Management System: Design and/or maintenance of quality management systems to ensure compliance and efficiency in PV activities.
Operational Pharmacovigilance Support
Managing day-to-day PV activities can be complex and resource-intensive. Our experienced consultants provide comprehensive support, ensuring all aspects of your PV operations run smoothly. Our services in this area include, but are not limited to:
Handling Safety Information: Support for managing safety information from product quality complaints, medical inquiries, and solicited activities (e.g., registries, market research, patient support programs, company-sponsored social media activities).
Adverse Event Management: Development of adverse event and pregnancy forms. Processing, analysis, reporting, and follow-up on adverse events, as well as AE reporting requirements training.
Clinical Trial Support: Review and input into clinical trial protocols, investigator brochures, clinical study reports, safety management plans, and medical monitoring plans.
Pharmacovigilance Audits: Conducting on-site or remote audits of internal global and affiliate PV departments, as well as audits of contractual partners and providers.
Medical Information Management: Providing medical information support and managing medical inquiries.
Aggregate Safety Reporting: Preparation of global aggregate safety reports, including DSUR/ASR, PSUR/PBRER/PADER.
Advanced Pharmacovigilance Consulting
Our resources also provide strategic oversight and specialized expertise to enhance your PV system. Our services in this area include, but are not limited to:
Signal Management: Detection, evaluation, and management of safety signals to identify and mitigate potential risks.
Risk Management Plans (RMP) and the Development and maintenance of risk management plans and risk evaluation and mitigation strategies.
Benefit-Risk Communications: Providing clear and effective communications with competent authorities regarding benefit-risk assessments.
Regulatory Inspection Support: On-site or remote support before, during, and after regulatory inspections to ensure compliance and readiness, including CAPA plan development and management, and through completion.
Strategic PV Consulting: High-level strategic PV assessment, analysis, and oversight to ensure your PV system is robust, compliant, and responsive to evolving safety needs.
Safety Variations and Urgent Safety Restrictions: Management of safety variations and implementation of urgent safety restrictions to ensure ongoing product safety.