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.
Why DSCSA Compliance Matters
The Drug Supply Chain Security Act was implemented to safeguard the pharmaceutical supply chain from counterfeit drugs, ensuring patients receive genuine, safe medications. Non-compliance with DSCSA regulations can lead to severe penalties and reputational damage. Our services are designed to help you navigate these complex regulations seamlessly.
Learn more about the Drug Supply Chain Security Act →
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.
Why Choose ProPharma for DSCSA Compliance?
Global Expertise
With our extensive experience in the pharmaceutical industry and global serialization requirements, we are well-equipped to handle diverse compliance challenges across different...
Efficiency and Accuracy
Our meticulous approach to electronic alerts, PQCs, and authenticity verification guarantees swift and accurate handling of serialization-related cases.
Cost-Effective Solutions
By outsourcing your serialization management to ProPharma, you can streamline operations and reduce the burden on internal resources, ultimately saving costs.
Comprehensive Support
From intake to closure, our services cover all aspects of global serialization management, providing you with a hassle-free compliance experience.
Regulatory Compliance
We stay up to date with the latest regulatory changes to ensure that your serialization processes always align with current standards.
DSCSA Articles
August 15, 2023
What is the Drug Supply Chain Security Act (DSCSA)?
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
News & Insights
December 23, 2024
Excelling in the JAPAC Medical Information Landscape: Key Considerations and Insights
Discover strategies for establishing a medical information function in JAPAC, overcoming diverse regulations, data privacy laws, and cultural nuances.
December 23, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
News & Insights
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
