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

August 15, 2023

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....

September 25, 2023

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

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.

PMA Post-Approval Study Considerations

October 7, 2024

PMA Post-Approval Study Considerations

Learn the essential considerations for conducting Post-Approval Studies (PAS) for medical devices, including protocols, timelines, and reporting requirements to ensure compliance with FDA regulations.

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Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

ProPharma Names Dawn Sherman Chief Executive Officer

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.

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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Names Dawn Sherman Chief Executive Officer

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.

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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Previous Post Arrow Next Post Arrow
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.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

Previous Award Arrow Next Award Arrow
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.

PMA Post-Approval Study Considerations

October 7, 2024

PMA Post-Approval Study Considerations

Learn the essential considerations for conducting Post-Approval Studies (PAS) for medical devices, including protocols, timelines, and reporting requirements to ensure compliance with FDA regulations.

What is a Clinical Evaluation Report (CER)?

September 30, 2024

What is a Clinical Evaluation Report (CER)?

Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow