regulatory compliance isn’t optional
The Federal Drug Administration (FDA) has put the pharma industry on notice with a crackdown on regulations. Already in 2023, the FDA has issued 164 Warning Letters, 44 of them directed at pharmaceutical companies! With this level of scrutiny, compliance isn’t optional for the pharma industry.
the serial # on the bottle is as important as the label
With the DSCSA 2023 requirements, the serial numbers on the pharma bottles are under more scrutiny. With this required serialization comes additional process & resources. Are you set up effectively & efficiently?
are you compliant, effective, and efficient?
It can be difficult to assess your own process when you’re working in the middle of it; an outside perspective provides a thorough, unbiased, fresh look. At Vantage, we provide the best solutions that are not tied to a vendor. We work for YOU and not a vendor.
serialization retained services:
we provide single engagement or ongoing support for Manufacturers, CMOs / CPOs, Re-packagers and Virtuals
identify
• Understand customer goals
• Review markets served
• Assess regulatory requirements
• Map As-Is supply chain process
analyze
• Evaluate capabilities and systems (shop floor to enterprise-level)
• Perform gap analysis
• Generate risk assessment
• Create To-Be supply chain process
guide
• Detailed findings report
• Update or create procedures
• Evaluate and help select vendors
• Develop validation plan
consult
• Interpretations of FDA, EU or other country regulations and guidances
• Time available with consultants/SME’s in key areas (automation, validation, IT, etc) on a regular basis for questions
Track and Trace Regulatory Guidance
Expertise to guide your company through DSCSA 2023, EUFMD, and other global serialization legislation.
strategic guidance
Our decades of experience allows us to see the full scope of your process challenges. We help select and implement systems that support new product launches, increase productivity, and comply with regulatory mandates.
streamlined serialization and traceability
Implement product tracking through all stages of manufacturing and distribution. Cost effectively comply with global track and trace regulations.
supply chain systems integration
Our team has extensive experience in Network Integration and Industry Standard Protocols (GS1, EPCIS), Level-4 Systems Integration and Security, Warehouse and Inventory Management solutions, and more.
process and manufacturing efficiency
With a holistic view of the entire process, we have a keen focus on a standardized, seamless integration of each operation. This leads to very efficient, compliant implementations whether in-house or at partner sites.
validation
Our associates have been involved with the validation of systems across all life sciences industries, from pilot scale to commercial manufacturing.
ongoing support
Vantage offers on-going technical and compliance support services. We’re set up to complement your internal team and provide immediate, expert help.
2023 readiness
For organizations facing safety, quality or efficiency challenges, we provide strategic guidance and cost-effective execution of initiatives to improve patient safety. Our team is seasoned, lean, on time and within budget.
Vantage helps your company with:
• current system evaluation
• gap analysis and recommended architecture
• current and potential vendor cost review
• implementation analysis