DSCSA Compliance and Serialization Services

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COVID-19 Update- FDA Authorizes Pharmacists to Prescribe Paxlovid

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 →
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Our DSCSA Compliance & Serialization Services

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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.

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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.

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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.

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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.

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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.

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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.

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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?

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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...

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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 markets.

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Efficiency and Accuracy

Our meticulous approach to electronic alerts, PQCs, and authenticity verification guarantees swift and accurate handling of serialization-related cases.

Efficiency and Accuracy

Our meticulous approach to electronic alerts, PQCs, and authenticity verification guarantees swift and accurate handling of serialization-related cases.

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Cost-Effective Solutions

By outsourcing your serialization management to ProPharma, you can streamline operations and reduce the burden on internal resources, ultimately saving costs.

Cost-Effective Solutions

By outsourcing your serialization management to ProPharma, you can streamline operations and reduce the burden on internal resources, ultimately saving costs.

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Comprehensive Support

From intake to closure, our services cover all aspects of global serialization management, providing you with a hassle-free compliance experience.

Comprehensive Support

From intake to closure, our services cover all aspects of global serialization management, providing you with a hassle-free compliance experience.

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Pharmacovigilance

Regulatory Compliance

We stay up to date with the latest regulatory changes to ensure that your serialization processes always align with current standards.

Regulatory Compliance

We stay up to date with the latest regulatory changes to ensure that your serialization processes always align with current standards.

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Partner with ProPharma Today

Managing global serialization can be complex and demanding, but with ProPharma by your side, you can have peace of mind knowing that compliance is our top priority. Let us handle the day-to-day aspects of serialization management while you focus on your core business objectives.

DSCSA Articles

What is the Drug Supply Chain Security Act (DSCSA)?

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....

DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)

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

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ProPharma Recognized for AI Excellence at ECCCSA

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ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

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Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

News & Insights

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Discover how ProPharma's medical information services in the Netherlands ensure patient safety, regulatory compliance, and data privacy with expert support.

Tips for Preparing Successful FDA 510(k) Submissions

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Tips for Preparing Successful FDA 510(k) Submissions

Discover essential tips for preparing a successful FDA 510(k) submission. Learn common pitfalls to avoid, align with FDA expectations, and streamline your path to clearance.

FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2025

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FDA’s Crackdown on Drug Advertising: Key Lessons from 60 Compliance Letters in 2...

Insights from FDA’s latest round of compliance letters which indicates a major shift in ad promo oversight revealing new compliance risks for Sponsors.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

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.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

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.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Whitepapers Your Complete FDA 510(k) Premarket Notification Checklist

September 30, 2025

Your Complete FDA 510(k) Premarket Notification Checklist

Step-by-step guide to navigating the FDA 510(k) submission process with confidence Submitting a 510(k) premarket notification is a critical milestone for medical device manufacturers seeking U.S....

Infographic Unannounced FDA Inspections Without Borders - ProPharma

September 19, 2025

Unannounced FDA Inspections Without Borders

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities,...

Case Study Leading Technology Selection Decision Making - ProPharma

September 15, 2025

Leading Technology Selection Decision Making

Discover how ProPharma enabled a leading global biopharma to overcome fragmented clinical sample management and outdated manual processes. Faced with disparate systems, off-site inventories, and...

Previous Resource Arrow Next Resource Arrow
AI in Medical Information: Who Holds the Responsibility?

October 16, 2025

AI in Medical Information: Who Holds the Responsibility?

In Medical Information (MI) and beyond, key questions arise: Who ensures accuracy, compliance, and ethical use — individual contributors, leadership, pharma clients, or technology providers? And what...

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

September 25, 2025

Improving Patient Health and Safety through Pharmacovigilance and Medical Information Synergy

Medical Information (MI) and Pharmacovigilance (PV) work together to protect public health by identifying and evaluating emerging safety signals. Watch our in-depth webinar, where our experts explore...

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

September 23, 2025

Navigating the Review Process: Optimizing MLR Meetings for Speed and Compliance

Medical, Legal, and Regulatory (MLR) review meetings are a critical checkpoint in the promotional material approval process, but they’re often a source of bottlenecks, conflicting feedback, and...

Previous Webinar Arrow Next Webinar Arrow