Drug Enforcement Administration's (DEA) enforcement of suspicious orders tracking. Regulations in 21 C.F.R. 1301.74(b) have been confusing DEA registrants and DEA’s own agents and investigators. There is a need for these suspicious order monitoring programs to be clear & compliant to the norms. Our experts provide custom developed, SOM statistical modeling & integrate it either in your existing order management system or parallel as cloud environment to improve your defense during a DEA investigation. With fresh orders entering the customer’s order management system, our tools enable you to compare relevant data from each order against past sales order accounts. Our tools apply careful in-depth scrutiny to each line item to identify orders deviating substantially in size, frequency and pattern. If a customer does not have sufficient order history to run the validation tests, Thresholds and Peer Group analysis may be used until adequate history is acquired. We thrive to bring a supreme quality and combination of industry-leading regulatory expertise to help you comply with the DEA’s regulations. Our seasoned experts in statistical analysis team develops life sciences industry-specific statistical models and has been known for assisting manufacturers, distributors, chain pharmacies / grocers, and more in improving their Suspicious Order Monitoring compliance. Also we bring to the table a lot of experience in employing industry leaders like regulatory bodies helping our team having strong foundations in the analyzing fraud & abuse in real time and a more reliable way. Also provide trainings to your staff to empower them and being more due diligent leveraging our relationships with regulatory authorities who bring to the table their real world experiences during trainings.
Below are the services provided:
1. Catalyze getting DEA registrations
2. Assessments, reviews and inspections
3. Operation set up, records and reports
4. SOP reviews
5. Assessment reviews
6. Training & coaching
7. Registration and approval assistance
8. Suspicious order monitoring
9. Customer due-diligence assistance
Our solutions help you achieve operational excellence with reliable brand image. Some states are sterner than the federal rules. We always take state laws in consideration during civil, administrative or criminal actions are under the watch. The granting of a DEA registration signals only a proper application, the establishment of the required records system, and the required security system at the time of the on-site inspection by DEA. The registration is not a confirmation of proper ongoing business practices and does not relieve the chemical handler of the responsibility to evaluate such transaction.