Medical Information

Adverse event & product complaint management

Management of events from recognition to submission

Supporting and reassuring you with a complete range of high-quality services.

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Mary Anne Greenberg

t+1 212 353 8532

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Regulatory agencies are increasingly placing more pressure on life science organizations. This means there’s more importance than ever for timely and accurate submission of adverse event (AE) reports and product quality complaints (PQC). With Ashfield on your side you’ll have complete peace of mind that we’re handling every aspect, from start to finish. Our services are not only comprehensive, they are among the best in the industry.

• Initial AE intake case handling and follow-up:
- Domestic and global cases
- Medical products/device products or investigational drugs/device products
- Serious and non-serious
- Post-marketing, clinical trial, solicited reports, literature searches and legacy cases
• Case entry into safety and surveillance systems
• Case quality review
• PQC intake case entry into database
• Facilitation of pharmacy exchanges
• Facilitation of product retrieval for investigational purposes
• Reconciliation of all reports and cases

Ashfield Pharmacovigilance, like us, has over a decade of pharmacovigilance (PV) experience and a reputation for high quality services. Their comprehensive range of safety experience covers the pharmaceutical, biotech, consumer health/over-the-counter, medical device and animal health categories with full-service solutions including:

• Comprehensive Case Management
• Safety Database & Information Technology (IT) Services
• Global Aggregate Report Development
• Literature Services
• Risk Management Services
• Signal Detection & Management
• Risk Evaluation & Mitigation Strategies (REMS)

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