The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.
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- Bacterial Endotoxin Testing, Part 3: Calculating Endotoxin Limits & MVD
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ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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A Smart, Data-Driven Approach To Formulate Biotherapeutics For PFS
Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.
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Building Sustainability Into Medical Devices
Medical device waste is a growing problem in the pharmaceutical industry. Learn how to navigate the balance between sustainability and factors like performance, safety, and regulatory compliance.
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Partnership Goals For Scale-Up Success
As demand for capabilities and resources grows throughout a project, both become strained in-house and the scale-up process becomes a steeper hill to climb.
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Liposomes – Challenges And Opportunities
Liposome technology is an effective drug delivery tool but still presents difficulties. Learn how developers are meeting these challenges and the opportunities for advancement to maximize liposome usefulness.
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An Easy-To-Swallow Depression Drug For Elderly Patients
Examine how an innovative formulation approach helped a developer create a version of their drug that promotes treatment compliance within the geriatric population.
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Improved Biomanufacturing Processes And Drug Product Stability
Improve upstream media for bioavailability and foam stability, downstream buffers for purification, and the formulation and final fill drug product stability with this highly interdisciplinary process.
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Solutions For Accelerated Pharmaceutical Development
Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.
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Containment Solutions To Help Emerging Biologic Companies
Set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
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Delivering On GLP-1 Demand: Combining Device And Supply Strategy
Meeting the demand for GLP-1 treatments requires robust and efficient delivery systems. Review how innovative solutions offer customization, streamlined manufacturing, and formulation compatibility.
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The Growth Of Sterile Injectables
Learn why partnering with a manufacturer capable of delivering flexible aseptic fill-finish solutions for any size production run is essential for delivering products to patients safely and efficiently.
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FRANKLY FRAN
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The growth of combination products in the market, as well as new quality and regulatory standards that apply to them, are driving the increased significance of suppliers. Every drug device combination product will utilize third parties for various services, constituent parts, or other components. In this article, Fran DeGrazio lays out five foundational considerations for implementing an effective supplier/purchasing controls process.
- Preparing For The FDA QMSR: Will You Be Ready?
- Setting The Bar For Drug Product Quality, Part 2: The Evolving Practice Of Particle Testing
- Setting The Bar For Drug Product Quality, Part 1: How Best Practices Prevail
- Embrace Packaging and Delivery Systems Designed for Today's Standards
- The Key to Regulatory Innovation? Global Harmonization
- Organizational Imperatives For Combination Product Development