We enable Life Sciences companies to achieve the license validation requirements for DSCSA/DQSA and VAWD authentication compliance. In order to tighten the country's drug supply and prevent counterfeiting, The Drug Quality and Security Act (DQSA / DSCSA), requires that all trading partners be authenticated with the proper licensure for distribution activities. The law includes facilities from which you receive products, those to whom you are passing title, and the facility to which you are shipping. In addition, all wholesalers and 3PLs must be registered with the FDA.
Fewer Hold Orders!
SLS does not rely on monthly or weekly data feeds from state regulating boards. Unlike our competitors, we hand verify, cleanse, and authenticate state and federal credentials for all ship-to's, sold-to's, and vendors, providing you with an active portfolio of validated state and federal credentials according to your product line and distribution model. Our competitors rely upon monthly data dumps from regulating boards, resulting in large numbers of hold-orders, forcing your employees to contact the facility or regulating board to secure proof of licensure before shipping or receiving.
We do the heavy lifting
Our skilled technicians contact regulating boards on our client's behalf to obtain evidence of active licensure daily, keeping your shipments moving. FDA and DEA registration information is cross-referenced in real-time. You can access your authenticated portfolio via online portal access, Excel export, or direct integration into your ERP. This flexibility, our timely services, as well as our competitive pricing, make choosing SLS for authentication compliance a smart choice.
Who benefits from SLS?
Small to large-sized self-distributing facilities who need a vendor to provide trading partner authentication to meet DSCSA/DQSA standards as well as VAWD credentialing requirements benefit the most from SLS's services.
Virtual manufacturers and virtual wholesalers. Your 3PL will only go so far when it comes to verifying licensure and it ultimately is your responsibility when a state issues a complaint against you for unlicensed activity. Most 3PLs only require an initial copy or proof of licensure when you add your trading partner to their ERP. Will they check to make sure your wholesaler and 3PL customers are reporting to the FDA on a regular basis as required by DQSA? Do they follow-up with your customers when licenses are renewed? 3A PL will generally only check licensure status of the ship-to. If the ship-to address is different than the sold-to address to which you pass title, the 3PL will not validate required licensure of the sold-to as well.
If you're using a different validation service, it's worth considering whether your ERP has a built-in verification service that checks state licensure. While having this service integrated is a great feature, it's important to understand what happens when it identifies a potential hold order. Does the service proactively investigate why there's a hold, and reach out to the relevant parties (such as the trading partner or the board) to address the root of the problem? Unfortunately, the answer is likely no, and the burden falls on your customer service team. Your customer service manager can attest to the fact that this process can feel like constantly pushing water uphill, and it takes valuable time away from serving your customers. Consider asking your Customer Service Department if SLS may be a solution to this daily bottleneck.
