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Getting the Support You Need at Every Step of the CE Marking Process

CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark is a must for placing products on the market. With the implementation of the EU...

Clinical Research: Phase 1 - Phase 4

5 Stages of Medical Device Development

Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...

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Building Flexibility into Your Medical Device Launch Strategy

A dilemma that medical device developers often face is where to launch their products first—whether it’s in Europe, the US, or both. In our experience, the decision of which initial market to target should not be taken lightly and should be guided by more than just the path of least regulatory resistance. Instead, successful launch...

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The Economics of Investigational Device Exemption (IDE) Studies: What You Need to Know About Medicare Coverage

Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also...

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Conducting Clinical Studies Under an Investigational Device Exemption

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness.1 This exemption applies to the conduct of trials necessary for developing new medical devices. Most often, clinical studies are conducted to support a Premarket Approval (PMA) application, though some 510(k) submissions...

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Is Your In Vitro Diagnostic Exempt from Investigational Device Exemption Regulations?

An investigational device exemption (IDE) allows an investigational device to be used in a clinical study for the purpose of collecting safety and effectiveness data.1 However, many in vitro diagnostic (IVD) devices are released from IDE regulations if certain criteria are met. In this blog post, we discuss how device studies are classified and explore...

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CMC Considerations for Pre-IND Meetings

The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical plans for...

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Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks of nitrosamine contamination and potential...

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Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

Meet Our Speakers: Dr. Olu AlobaVice President, CMC Services Dr. Marianthi KarakatsaniDirector, CMC Development Strategy

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Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals: 2023 RAPS Article of The Year

October 19th, 202311:00 a.m. EDT Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks...