Safety and Crisis Management

We recognize that patient and customer safety is your biggest priority. We offer full-service pharmacovigilance, REMS, product complaint, and recall solutions to address safety problems with immediacy, sensitivity and accuracy.

Adverse Event Reporting/Pharmacovigilance

Our pre- and post-marketing solutions complement your existing drug safety operations and mirror your corporate policies. Patients, consumers and providers communicate with medical professionals experienced in adverse event (AE) and product quality complaint intake, processing and documentation. Our highly skilled agents monitor web sites, emails, and phone calls to help identify AE/SAEs and then take appropriate steps to quickly document and report them to appropriate stakeholders and regulatory bodies.

Risk Evaluation and Mitigation Strategy Support

We administer universal education programs to healthcare professionals and patients on the safe and appropriate use of products via direct mail, telephone, web and field teams. Programs are intelligently designed to address product-specific risks and to ensure full compliance with FDA directives and prescriber lists.

Product Return and Recall

When the potential for brand impact is highest, we respond quickly and knowledgably with vital information that demonstrates your commitment to customers. We employ a variety of methods to mitigate a crisis within hours of notice, including customer notification throughout the supply chain, safety alerts, collection and disposal of products, traceable direct deliveries, and regulatory reporting.