Pharma Process Validation: Where Do We Start?

Whether you are new to pharma, new to validation, or new to both, understanding how to prove the efficacy of pharmaceutical processes is a safety and regulatory imperative. Process validation is not something that’s “nice to do” – it’s something that must be done. And for good reason. The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make […]

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Drug, Device, or Both? Overview of FDA Premarket Regulation of Combination Products

A vaccine in a prefilled syringe. A metered-dose inhaler. A nicotine patch. A drug-eluting stent. These are examples of so-called “combination products” that mix drug, device, and/or biologic. They are among the most closely scrutinized products by FDA, European, and other authorities. While these combination products are subject to overlapping regulatory oversight, their compliance pathway is not always clear-cut. In this article, we will explain the basics of how they are regulated. Examples of Combination Products Before we take a […]

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FDA Regulatory Requirements for Medical Device Software (SaMD and SiMD)

Even seasoned regulatory professionals struggle to understand the myriad regulatory requirements pertaining to medical device software. A bewildering morass of national regulations, guidance, international standards, and overlapping documents make coding seem like the easy part. Fear not – in this article, we will give you a mountain-top view of your obligations and where to find the information you need to ensure a successful submission and ongoing compliance. Let’s start with US FDA requirements. How Does US FDA Regulate Medical Device […]

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List (with Links) of Important Medical Device Software Standards

If you’ve done any research on regulatory requirements for medical device software, you know there is a bewildering array of documents out there covering everything from AI to UDI. Clients often ask us which documents are most relevant, so we’ve put together this list as a helpful resource. By all means, don’t assume this is a comprehensive list of every requirement related to software. The US FDA, for example, publishes 600+ medical device guidance documents, many of which are focused […]

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