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3 Regulatory Guidelines for Navigating China's Drug Delivery and Medical Device Markets

As the world's second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia. For companies familiar with doing business in the U.S., navigating the regulatory pathway of the Chinese Food and Drug Administration can be a challenge. This white paper shares three guidelines to help facilitate a deeper understanding of the CFDA's regulations.

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3 Regulatory Guidelines for Navigating China's Drug Delivery and Medical Device Markets
Using Device Strategy to Drive R&D Productivity

Devices are increasingly important in drug delivery. Learn how to improve overall R&D effectiveness by developing a robust device strategy.

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Using Device Strategy to Drive R&D Productivity
Critical Considerations for High Viscosity/High Volume Drug Delivery Devices

High viscosity and/or high volume drugs require special attention from device developers, particularly when associated with biologics. As the use of biologics continues to increase, early involvement between the drug manufacturers, device designers and device manufacturers is critical to the development of the most efficient overall strategy of drug/device life cycle.

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Critical Considerations for High Viscosity/High Volume Drug Delivery Devices
How OEMs Achieve Complexity, Precision, Strength – and Savings – with Metal Injection Molding

Metal injection molding can produce relatively small, highly complex geometries with excellent surface finish, high strength, and superior corrosion resistance – with no scrap.

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How OEMs Achieve Complexity, Precision, Strength -- and Savings -- with Metal Injection Molding
The First Step To Navigating Your Combination Product's Regulatory Pathway: Defining the Primary Mode of Action (PMOA)

As the drug-device combination product market continues to grow at a rapid pace, it is important for companies to avoid unnecessary delays and gain speed to market with 'right the first time' regulatory submissions of their combination product. The first step is determining a product's regulatory pathway.

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The First Step to Navigating Your Combination Product's Regulatory Pathway: Defining the Primary Mode of Action (PMOA)
Bringing Metal Parts to Life with Complex Geometry and Precision Tolerances

Metal injection molding is an effective way to produce complex and precision-shaped parts from a variety of materials, in low to extremely high volume capabilities, as well as effectively and with significantly reduced lead times.

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Bringing Metal Parts to Life with Complex Geometry and Precision Tolerances
How Safe Is Your Battery?

The increase in portable electronic devices, has also increased the demand for the batteries that power them. However, batteries are susceptible to failure, particularly when physically damaged or breached, potentially causing a fire, explosion, or hazardous leak. Phillips-Medisize's impact-resistant battery technology has the potential to help minimize harm to property and lives, while enhancing the safety of devices that run on rechargeable lithium-ion batteries.

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How Safe Is Your Battery
Device Development for Pharmaceutical and Biologic Combo Products

When developing a combination product, there are many things to consider. But the opportunity for success is greater with early design involvement as well as careful consideration of the knowledge needs of everyone involved.

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Device Development for Pharmaceutical and Biologic Combo Products
Keeping the Patients at the Center of Drug Delivery Devices

Learn how incorporating a human-centered design approach can ensure patient usability, save money and drive the trend toward development of smaller and smarter, next-generation devices.

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Keeping the Patient at the Center of DDD
6 Guidelines To Follow When Developing Combination Products

Development of a combination product comes with significant patient benefits, but that reward can be offset by the range of regulatory complexity and uncertainty encountered with bringing a product to market, in addition to any post-marketing activities. This white paper includes 6 guidelines to improve the odds of first-time regulatory approval, thereby enabling speed to market.

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6 Guidelines To Follow When Developing Combination Products white paper

 

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