Help With Serialization

Drug Supply Chain Security Act (DSCSA) Compliance

Our serialization team has worked with small and large pharmaceutical companies. We have supported single-line and multi-line packaging operations with varying levels of automation. We can help you choose the systems that are right for you, and provide you confidence that your operations are compliant today, in 2023, and beyond.

PharmaSys is a leader in FDA compliance and understands serialization requirements.

We have the experience necessary to successfully implement your serialization program.

PharmaSys is an industry leader in providing item level serialization services to the pharmaceutical industry. We understand and provide services for:

  • Project Management

  • Gap Analysis

  • Requirements Definition (Business and Regulatory)

  • Possible Serialization Strategies

  • Requests for Proposal

  • Vendor Evaluation and Selection

  • Contract negotiations

  • Vendor Audits

  • GS1 Prefix Registration

  • GTIN Identification

  • Transaction Information, Statement and History

  • Updates to Standard Operation Procedures

  • Updates to Master Production and Control Records

  • Process and Computer System Validation

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