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Identify DSCSA Regulatory Gaps Before They Hurt Your Business

By March 9, 2016March 16th, 2021DSCSA, Serialization

Imagine this: The FDA has arrived at your business. The agent, tablet in hand, is prepared to inspect your company’s regulatory compliance processes related to the Drug Supply Chain Security Act (DSCSA). All of them. You and your team escort the agent around the facility, confidently explaining processes and supplying them with extensive Standard Operating Procedure (SOP) manuals and Good Manufacturing Practices (GMP) documentation. The inspection reveals no gaps in your serialization compliance, and you and your team get back to work without needing to spend time or money on remediating issues.

As a manager or executive in the pharmaceutical industry, you likely have this scenario running through your mind several times a week. But, if you haven’t undergone a gap analysis directly related to the DSCSA regulations and serialization, you’re probably not as confident in the outcome.

LSPediA Gap Analysis: Compliance Confidence – Plus Process and Product Improvement
There’s a lot riding on complying with serialization and DSCSA regulations: The market can be quick to punish drug companies that don’t make product quality or patient safety THE top priorities. Plus regulatory penalties and shipment quarantines could have long-term negative effects on your business’s bottom line and its ability to compete.

LSPediA is helping pharmaceutical manufacturers identify and correct compliance gaps related to serialization and other U.S. and global regulatory mandates. Here’s our process:

  1. Compliance Gap Analysis Audit: Determine compliance readiness for all of your products and services, identify the areas for improvement, and recommend changes needed to achieve compliance objectives per country.
  2. Remediation Action: Recommendations are assigned to functional groups along with training and action plans; LSPediA manages the remediation process through weekly review meetings to ensure all actions are compliant, permanent, and preventative in nature.
  3. Final Audit and Compliance Letter: LSPediA confirms compliance of all analyzed and remediated systems, products, services, and documents. An audit report and compliance letter are issued following a successful demonstration of adherence to regulations.

To understand your compliance needs, we engage with a large cross-section of stakeholders, including functional groups, customers, suppliers, and solution providers. This ensures a comprehensive analysis of your environment, and a personalized solution that will help your business:

  • Meet regulatory compliance
  • Improve consumer confidence
  • Build brand equity
  • Avoid regulatory penalties
  • Prevent shipment interruption
  • Strengthen market position

Let’s Talk Today – DSCSA Deadlines are Just around the Corner

The DSCSA’s next set of compliance deadlines are about 18 months away – and now is the time to prep
are. To get a complete understanding of the gaps in your company’s compliance processes, contact LSPediA today. Working together, we’ll develop a customized analysis and remediation plan that’s just right for your business.