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  • Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace
    Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

    From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

  • Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions
    Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions

    Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

  • 4 (More) Critical Considerations For Drug Delivery Device Development
    4 (More) Critical Considerations For Drug Delivery Device Development

    Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

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Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions

Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

4 (More) Critical Considerations For Drug Delivery Device Development 4 (More) Critical Considerations For Drug Delivery Device Development

Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

What Organizational Design Says About Your Commitment To Data Integrity What Organizational Design Says About Your Commitment To Data Integrity

Understanding how to be appropriately staffed and being prepared to explain any perception of inequity could mean the difference between success and failure of appropriate data integrity in both regulatory compliance and product support.

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TITLE SUMMARY DISPLAY

  • Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

    From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

  • Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions

    Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

  • 4 (More) Critical Considerations For Drug Delivery Device Development

    Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

More From Pharma Contributing Editors

GRID WITH IMAGE DISPLAY

Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace Aggregation 101: Connecting The Dots Between Pharma Serialization And Track-And-Trace

From “serialization” to “coding” to “track-and-trace,” the pharmaceutical industry is rampant with terms that point to the quest for transparency. The latest of these is “aggregation,” a burgeoning method of data collection aimed at simplifying inventory and the supply chain. While still in its infancy, the technique can help to combat counterfeiting, theft, inefficiencies, and confusion as a whole. Yet, with every new process comes challenges, requiring manufacturers considering aggregation to seek best practices for implementation.

Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions Decoding FDA’s Refuse To Receive (RTR) Standards For ANDA Submissions

Though the FDA has laid down clear steps for abbreviated new drug application (ANDA) submissions, applicants still struggle with the procedural challenges in preparing and submitting their applications. As such, it is important to dig deeper into the process and understand the possible reasons why the FDA may refuse to approve — or even refuse to receive (RTR) — an ANDA submission.

4 (More) Critical Considerations For Drug Delivery Device Development 4 (More) Critical Considerations For Drug Delivery Device Development

Today, injection devices are a staple among biologic and other pharmaceutical products. With the exception of oncology products, the majority of biologic products today are launched as some form of combination product, which are stringently regulated by the FDA through 21 CFR Part 4. This article looks at important manufacturing, packaging, and other factors that developers of combination products must consider and why they need to be considered early in the device development program.

More From Pharma Contributing Editors