When it Comes to Compliance, Focusing on Case Processing Alone Isn’t Enough
Pharmacovigilance projects are complex and require solid project management. There are many departments involved that often operate in silos, which results in an inability to communicate effectively and duplicated efforts. Organizations can have multiple locations, each with their own set of processes. All these barriers should be broken to allow for complete harmonization across all departments.
It’s no longer enough being compliant with case processing alone. We encourage strategic thinking about Pharmacovigilance, which considers multiple factors and how they intersect.
We Create Global Pharmacovigilance Organizations
We’ve worked with Pharmacovigilance organizations for a long time, and we have mastered the regulations and understand the process. We recognize the effort it takes to become a forward-thinking organization, and we know how to support your transformation.
We Can Help You Transition From Domestic Operations To A Global Organization By
Key Offerings Include
Prepare For Success With Treximo.
Clinical Individual Case Safety Reports
We create regulatory-friendly reports for clinical and marketed products to ensure compliance. Our team delivers client-approved operation procedures such as submission-prepared paperwork.
Aggregation Of Safety Reporting
Our clients can’t afford to forego vital safety information regarding products. We develop periodic reports for a tactical regulatory response, plus country-specific reports.
Our services to help our clients meet product safety issues in an assured, proactive way. We back clients up daily with the progress of clinical and post-approval tactics. Our consulting and preparation services make up the expansion of essential safety specifications and risk minimization tactics.