Pharmacovigilance
Pharmaceutical and biotech companies face stringent pharmacovigilance obligations that demand continuous safety monitoring and timely adverse event reporting. Organizations must maintain vigilant surveillance of product safety profiles, submit adverse drug reaction reports within tight regulatory deadlines, manage complex signal detection and risk evaluation, prepare periodic safety reports across multiple jurisdictions, and maintain comprehensive pharmacovigilance systems that satisfy regulatory expectations. Many companies lack specialized pharmacovigilance expertise internally, struggle with resource constraints during peak reporting periods, face challenges implementing compliant safety databases and systems, and require EU-QPPV designation to fulfill regulatory obligations.
Non-compliance with pharmacovigilance requirements triggers severe consequences: regulatory sanctions and product suspensions, patient safety risks from undetected signals, delayed market authorizations and variations, and reputational damage that undermines stakeholder confidence.
Our Pharmacovigilance services provide pharmaceutical and biotech companies with comprehensive safety monitoring and compliance support, from individual pharmacovigilance activities to complete system implementation and ongoing management.
We execute essential safety monitoring tasks that ensure regulatory compliance and patient protection:
Literature Research – Systematic monitoring of medical literature for safety information relevant to your products
Adverse Event Management – Evaluation and timely submission of adverse drug reaction reports, including follow-up investigations and documentation
Safety Database Maintenance – Management of your company-specific pharmacovigilance database with accurate case processing and regulatory compliance
Periodic Safety Reports – Preparation of PSURs, PBRERs, and addenda to clinical overviews that meet regulatory standards and deadlines
Risk Management Plans – Development and maintenance of comprehensive RMPs that address identified and potential product risks
Signal Management – Continuous safety evaluation, signal detection, and risk-benefit assessment throughout product lifecycle
EudraVigilance Compliance – Management of XEVPRM/XEVMPD submissions and ongoing EudraVigilance obligations
We establish and optimize complete pharmacovigilance infrastructures:
System Setup and Optimization – Consulting and support for establishing, developing, and reviewing pharmacovigilance systems that meet regulatory requirements
PSMF Management – Creation and maintenance of your Pharmacovigilance System Master File with comprehensive documentation
SOP Development – Creation, review, and maintenance of pharmacovigilance Standard Operating Procedures
Training Programs – Comprehensive training for internal staff, sales forces, and medical affairs teams on safety obligations
Audit Services – Conducting internal pharmacovigilance audits that identify compliance gaps and improvement opportunities
Inspection Support – Preparation and follow-up support for regulatory pharmacovigilance inspections
EU-QPPV Services – Designation of qualified personnel to fulfill Qualified Person for Pharmacovigilance, graduated plan officer, and information officer functions
EudraVigilance Consulting – Expert guidance on EudraVigilance registration, submissions, and ongoing compliance
Pharmacovigilance demands specialized expertise, systematic processes, and unwavering attention to regulatory requirements. Our comprehensive services ensure your safety obligations are fulfilled expertly while you focus on bringing therapeutic innovations to patients.
Contact us today to learn how our Pharmacovigilance services can strengthen your safety monitoring and ensure regulatory compliance across all markets.
