Solutions

Ensuring Compliance with Safety Reporting Regulations

Take the necessary steps for safety reporting regulation compliance.

Compliance_Monitoring
Quality and compliance monitoring
Root-Cause-Analysis
Root cause analysis
Audit-Inspection-Readiness
Audit and inspection readiness
Preventative-Action
Corrective Action/Preventative Action (CAPA) Management
Reporting
Reporting and analytics

CONSULTING SERVICES

Professional Guidance

Our business transformation and compliance consultants will help you gain confidence in your organization's ability to comply with regulations, reduce business risk and focus resources on higher value-added tasks. We will provide:

Education and training
We will train you on current and upcoming PV reporting and regulatory requirements, what these mean for your business processes and provide technical solutions where needed.

Inspection readiness
Our mock inspections will “test” your processes to better prepare you for an audit.

Organizational preparedness
Assurance that your department understands the workflows and tools necessary to monitor quality and maintain compliance.

Post-inspection management
We will help ensure that your audit findings are integrated into department procedures.

Regular health checks
We will make recommendations on the steps required for compliance.

TECHNICAL RESOURCES

Global Compliance Monitoring Software

Our proprietary solution, PV Monitor allows you to proactively monitor individual case safety report (ICSR) submissions to health authorities. The tool extracts data directly from virtually any PV system for analysis and enables compliance departments to:

Case-Processing
Monitor case process performance
Track-Late-Submissions
Track late submissions
Root-Cause-Analysis
Perform root-cause analyses
Interactive-Dashboard
Produce interactive dashboards
Library-of-Reports
Draw from a library of standard reports

OUR MISSION

Dedicated to Your Success

We’ve worked with all the leading large global pharmaceutical companies as well as small, emerging companies that are gearing up to use a safety database for the first time. Regardless of company size, our goal is the same: to help ensure PV reporting compliance in the most efficient and painless way possible.