Are Your Patients Protected?
NovusLife safety consultants can provide you with services ranging from high-level strategy through to functional work-step support with case analysis, medical review, narrative writing or reporting to health authorities, partners and others. Our safety consultants have experience in direct patient care and industry-specific pharmacovigilance services to provide support when and where you need it. We provide MDs and other experts experienced in drug safety, pharmacovigilance and pharmacoepidemiology who understand the changing regulatory environment. NovusLife consultants have the expertise to make your drug safety operations more flexible, cost-effective, efficient and compliant.
SAE/AE Monitoring and Reporting
SAE/AE Narrative Writing
Annual Safety Narratives
Interim Safety Listings
Review and Assess In-House Safety Data
Prepare Periodic Safety Update Reports (PSURS)
Prepare and Review Risk/Crisis Strategies
Designs, Review and Implement Risk-Management Plans and Safety Surveillance Studies