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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‘Brick dust’ compounds require additional steps if spray drying is to yield a commercially attractive process. Explore three enabling technologies designed to improve drug solubility in organic solvents for spray drying.
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Early Decisions To De-Risk The Transition To Combination ProductsThe injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?
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Solutions For Challenging Compounds Using Softgel InnovationThe significant interest in semi-solid systems for the potential of extended release profiles has prompted researchers to develop alternative encapsulating systems.
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Overcoming Limitations To Achieve Uniform DosingAn immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.
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In her new column, Fran offers keen industry insights exclusively on Drug Delivery Leader.
FRANKLY FRAN
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![frankly-fran-better]( "5 Keys to Supplier/Purchasing Controls – And Product Quality")
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
FREE EBOOK: COMBINATION PRODUCTS
Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.
