Pharmacovigilance Services in USA

If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in USA, access to pharmacovigilance services in USA is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with U.S FDA pharmacovigilance regulations, the right PV partner shapes everything, signal detection, risk management planning, safety reporting, and successful market authorization.

The United States employs a comprehensive pharmacovigilance system, comprising two post-marketing surveillance frameworks:

• FDA Adverse Event Reporting System (FAERS) for pharmaceuticals and biologics, this system supports post-marketing safety monitoring and is structured according to ICH E2B standards, encoding reports using MedDRA terminology.
• Manufacturer and User Facility Device Experience (MAUDE) database for medical devices, reports are submitted by mandatory reporters (manufacturers, importers, user facilities) and voluntary reporters (healthcare professionals and consumers).

Reporting adverse drug reactions is voluntary for healthcare professionals, consumers, and patients, but mandatory for IND sponsors, manufacturers, distributors, importers, and user facility personnel. Submissions are made via the MedWatch website, utilizing separate voluntary and mandatory ADR reporting forms.

• + ICSR Processing & Submission
  • Triage of initial and follow-up ICSRs/SUSARs
  • Case processing via E2B(R3)-compliant systems, integrated with WHO-DD and MedDRA
  • Quality checks, medical reviews, and timely submissions
  • Maintenance of ICSR tracking sheets and reconciliation with clients
• + Risk Management and Labeling
  • Creation and upkeep of Risk Management Plans (RMPs) and REMS
  • Custom procedures to classify safety risks and deliver Drug Safety Solutions in USA
  • Assessments of potential risks with recommendations for mitigation
  • Implementation of supplementary measures including PASS, observational studies, and follow-up questionnaires
  • Clear risk communication through labeling documents (Prescribing Information and Medical Guides)
• + Aggregate Reports
  • Preparation of PBRERs, DSURs, and ASRs as part of pharmacovigilance solutions USA.
• + Signal Management
  • Detection of new safety signals via ICSRs, literature reviews, and regulatory monitoring
  • Use of in-house tools and databases to manage signal tracking
  • Review of signals for ICSRs and aggregates, with recommendations based on PRAC guidelines
  • Label update analysis, risk minimization approaches, and preparation of signal trackers and annual signal reports
• + PV Compliance
  • Authoring and reviewing SDEA agreements, PV SOPs, and more
  • Monthly reconciliation and compliance metric reports
  • Medical review in quarterly signal surveillance meetings
• + PV Audit & Compliance
  • Gap analysis of PV staff
  • Mock audits and audit plans preparing clients for inspections
  • Training on safety audits and inspection readiness, as a trusted pharmacovigilance consulting firm