Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.
According to over 200 life sciences companies surveyed, the number one challenge in speeding products from R&D to patients is quality management, which may surprise many executives that have spent the past decade focused on other issues like validation, regulatory, or supply chain.
Here, we will discuss the costs and risks of taking a fragmented approach to managing and moving drug supplies and will explain how those risks can be mitigated.
A solution to break down the silos that exist in the early stages of drug development could be what researchers need to facilitate—and expedite—the delivery of safe, effective drugs.
The choice of potential technology transfer partners can be bewildering. This article shares some of the factors that should be taken into account when making this decision.
Clinical trial protocol template can help investigators create high quality protocols that are consistent, well organized and contain all pertinent information needed to be properly reviewed. Read more!
Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls.
The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?
While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.
Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
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