Be Sure With Advasur

Advasur Solutions

Advasur is experienced in building FDA compliance systems. Our private sector experience includes auditing wholesalers for both manufacturers and retail pharmacy chains. Advasur has the advantage of working for both the government and private sector on pharmaceutical product and product data supply chain integrity audits.

Advasur 360™ Offers Value

For Dispensers

Unmatched quality and cost-efficient services as an outsourced one-stop advisory and compliance service focused on the pharmacy’s interests. With ever tightening product insurance claims scrutiny and reimbursement level reductions, the Advasur 360™ Services provide outsourced turn-key expertise and quality compliance services that protect the pharmacy so it can thrive. On average, outsourcing compliance responsibility to Advasur costs 10-15% of creating and maintaining compliance policies and processes internally.

For Buying Groups and Cooperatives

In the first year of providing auditing and product data analysis for pharmaceutical manufacturer administrative fees, Advasur discovered 6-8% of administrative fees were unpaid and undisputed. Advasur can identify unpaid fees, negotiate for payment, and help develop SOPs to better identify unpaid fees. The amount of disputed fees generally decreases over time as the buying group and the manufacturer establish SOPs for recording, transmitting product data, and addressing disputes.

Advasur’s DQSA/DSCSA
Compliance and Audit Services

Broken Down Into Three Groups

1

DQSA Repository Services:

Application Solution Providers (ASPs) focus on pharmaceutical manufacturers and/or wholesalers and provide software to limited shipping notice transmission services. To date, Advasur has not found ASP service providers that perform validation of the transmitted shipping notice data or audit the data while in transmission. Also, the ASP providers who service the pharmaceutical manufacturers may have conflicts with wholesaler customers who are Authorized Distributors of Record (ADR) for those manufacturers.

Both manufacturer- and wholesaler-led trading associations have expressed concern about costs of DSCSA implementation and may intend to push costs down to the pharmacy level. Advasur is owned by pharmacists who are focused on building DQSA compliance systems in the best interests of pharmacists and the patients they serve. Advasur has no conflict when adjudicating DQSA discrepancies between trading partners, as Advasur only has one client, the pharmacist!

2

Serialized Data Services:

Advasur has developed a Harmonized Product Code (HPC) system to correlate serialized and non-serialized drug products. The Advasur HPC was designed to accommodate and synchronize the 9 serialization schemas used in over 30 countries.

3

Prime Vendor and Direct Generic Manufacturer DSCSA Compliance Services:

Advasur audits wholesalers exclusively for pharmacies and performs audits for new manufacturer suppliers for pharmacies. These two types of audits provide in depth knowledge of other trading partners to ensure pharmacy adjudication issues are addressed fairly by other trading partners through which they are supplied.

The Value of Advasur's DSCSA ASN Compliance Services

Advasur 10 Services
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  • Customized DSCSA Compliance SOPs
  • Validation and Certification of Suppliers
  • Automatic Suspicious Order and Frand & Abuse Monitoring
  • Build out customized Shipping Notice Repository for ASNs, EPCIS, Electronic Packing Slips and Supplier Transaction Data Report
  • Setting up ASN AS2 Connections and Maintaining Dynamic Supplier database
  • Inspection of Shipping Notices while product in transmission
  • Validating ASNs, Storing and Retrieving to meet 48-hour inspection clock
  • Set up GS1 Connection to Register and maintain Verification Router Service connection with Suppliers
  • Aggregate and Provide DSCSA Compliance Reports
  • Call Advasur (1-800-971-6571) when the Inspector Arrives to assist with the inspection