Leading Pharmaceutical Manufacturer
Pharmaceutical Manufacturing / Distribution
The ChallengeEffective management of the controlled substance supply chain and navigation of the regulatory process with minimal costs and delays requires considerable time, effort and expertise. Detailed attention to compliance, thorough planning, robust risk-management capabilities and the skills for effective implementation. Understanding and complying with federal, local and, if applicable, global regulatory requirements of supply chain destinations are critical to prevent delays and penalties. The identification of “red flag” controlled substance orders and associated thresholds for customers is a ‘moving target” for most organizations. Most organizations have implemented a customized solution to monitor and comply with DEA controlled substance regulations.
Our healthcare unit has assisted one of the largest pharmaceutical manufacturers and distributors in the world by developing a regulatory/compliance application to monitor controlled substance shipments to their pharmacies and hospitals. The application delivers the scalability to meet the growth of their clients, the flexibility to monitor and adjust thresholds and meet FDA regulatory compliance. We have helped our clients get the most out of their investment:
- Scalable application to meet a growing client base
- Flexibility to adjust thresholds
- DEA required reporting
- Secure processes, procedures and controls
- Reduce false positive red flagged orders
Leveraging our vast experience and expertise, Our team has helped our client: Meet DEA regulatory compliance, mitigate DEA fines/penalties, increase sales and improve their overall financial performance.