DSCSA compliance and serialization services

Comprehensive Drug Supply Chain Security Act (DSCSA) Serialization Services

Ensuring patient safety and maintaining the integrity of the pharmaceutical supply chain are paramount for any healthcare organization. At ProPharma, we offer comprehensive Drug Supply Chain Security Act (DSCSA) compliance in the United States and serialization solutions globally to help your organization meet regulatory requirements with confidence. Our expert team is dedicated to streamlining your compliance journey while enhancing efficiency and patient well-being.

Our DSCSA Compliance & Serialization Services

Electronic Alerts Management

Stay ahead of the game with our efficient electronic alerts management service. We download and consolidate all electronic alerts received from relevant entities, ensuring you are promptly informed about any potential issues or non-compliant activities related to your products.

Product Quality Complaints (PQCs) Processing

Timely and accurate management of Product Quality Complaints (PQCs) is crucial to safeguard your brand reputation and patient safety. Our team diligently processes all cases that have received a false/negative response, treating them as PQCs. With our rigorous approach, we identify and address serialization-related concerns proactively.

Authenticity Verification Requests

To combat the rising challenge of counterfeit drugs and ensure the authenticity of your pharmaceutical products, we facilitate and manage the authenticity verification process as required by regulations. Our expertise in this area ensures that all necessary steps are taken to verify the legitimacy of products within the supply chain.

Technical Assessment Support

When cases require further investigation and technical assessment, we seamlessly integrate with your Product Quality Complaint (PQC) team. Our support ensures that the necessary information and data are provided to conduct a thorough technical assessment for any serialization-related incidents.

DSCSA Operational Support

Our experts help sponsors and contract manufacturers demonstrate operational compliance with Title II of the DSCSA. We can update Quality Management Plans, and create policies, procedures, and operational control checks to demonstrate that products distributed in the US follow the drug track and trace lot level and package level product verification steps. We support transaction information (TI), transaction history (TH), and transaction statements (TS) for transferring ownership allowing clients to provide applicable TI, TH, and TS to agencies within the required timeframe, including the enhanced package level tracing requirements being implemented on November 27, 2024.

Serialization System Validation

Our computer system compliance experts validate Serialization Systems to provide evidence that the software applications have been configured to conform with the requirements of DSCSA Subchapter H--Pharmaceutical Distribution Supply Chain, such as capabilities to assign unique, standardized identifiers (serial numbers), retain the history of assigned identifiers, and promptly respond to verification requests from external parties.

Follow-up and Communication

As part of our comprehensive service, we conduct thorough follow-ups with relevant stakeholders to ensure prompt actions are taken to resolve serialization issues. Clear and effective communication is key to maintaining compliance and efficiency throughout the supply chain.