Take the guesswork out of DSCSA Compliance

We help clients architect compliant DSCSA product traceability systems.

Provide DSCSA readiness assessment and analysis

Are you audit ready and able to prove it?

Our DSCSA readiness assessment helps you rest assured you are fully complying with the law and able to provide evidence in the event of audits.  We have developed a comprehensive playbook that can be used to measure readiness and construct a workplan for any areas requiring attention.  We leave this playbook as a deliverable so that it can serve your team in keeping compliance evidence up to date and ready for a state or federal audit.  We can also assist you in ensuring any barcodes you create or handle are scannable and following GS1 and HDA guidelines and recommendations to avoid the risk of negative customer impacts and costly rework.  We offer a variety of levels of assessments depending on your needs and complexity of business roles.  

We would be glad to schedule a free initial consultation to understand your challenges and discuss what type of assessment might make most sense to propose.

DSCSA subject matter experts

Confused about all the requirements of DSCSA, what is required and when?  Why spend years learning when we can bring our experience and network to support?

We have spent years understanding the complex requirements and implementing solutions and processes with all sectors of the US Pharmaceutical Supply Chain.  We provide training and consultation to help organizations understand the applicable DSCSA regulations and guidance. We will review and advise on product barcoding requirements including alignment with FDA, GS1, PDG and HDA guidance and specifications.  We have participated for years for clients in most of the industry workgroups and have helped form many of the standards and blueprints the industry is utilizing.  

We are happy to propose reasonable and fixed price options for training or consultation for individuals or groups in your organization.

DSCSA Related Services

RX Serialization Systems Integrator
Ten Count has experience with the leading, largest global solution providers, and has also helped clients implement systems to fulfill their track and trace needs.  We lead through any phase of implementation or stabilization and help find the systems that best align with a company’s future.
Product Verification Systems Integrator
It is important to understand what your company and impacted partners plans are to support DSCSA defined Product Verification.  Ten Count can provide services to your organization in order to better understand this new industry solution, to select a solution provider or develop a legacy systems.
GS1 EPCIS Messaging Integrator
Now that many global markets are packaging serialized prescription product, it is important to understand the GS1 EPCIS (Electronic Product Code Information Services) messaging that has become the most widely used standard in sharing product tracking event data with your trading partners.  Ten Count provides services to help identify requirements and guide you through a successful implementation.
Mark and Ten Count Consulting can support your company's DSCSA needs. It's never too late to start thinking about 2024 interoperability!" ‍
Current Client

Pharmaceutical Supply Chain Project Management

Why hire and train a new employee for a job that requires specific experience and has a limited horizon?

Our Project Management service can manage and help your company navigate all phases of a successful software and process implementation from budgeting and planning through implementation based on successful implementations.  We specialize in the implementation of serialization and tracing systems to support the US DSCSA (Drug Supply Chain Security Act).  We are also experienced at 3PL and commercial packaging vendor selections and implementation to serve as your independent partner focused on the needs of our clients.  More than a contracted worker, we strive on building long lasting relationships and becoming your trusted partner available when needed.  

We would be glad to schedule a free initial consultation to understand your challenges and how we might be able to serve.
“I wanted to thank you for an informative and good orientation session. I think the extended team now understand more about the DSCSA requirements.”
Chiasma Pharmaceuticals
Ready to grow your confidence in DSCSA compliance?