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

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

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

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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.

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.

Case Study From Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

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Avoiding Common Pitfalls During FDA Inspections

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Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

Navigating EMA and Global Regulations for Medical Information Services

July 24, 2025

Navigating EMA and Global Regulations for Medical Information Services

ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.

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
Case Study From Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina

Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...

Previous Resource Arrow Next Resource Arrow
Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow