In 2016 we released a paper, “4 Things You Need to Know About Combination Drug Compliance.” This paper is still entirely relevant today, and we...
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Combination Drug Products
Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes
WHITE PAPER Navigating the European Union’s (EU) Drug Device Combination Product Regulatory Changes The European therapeutics market has been working to manage the upheaval...
Live from the PDA Annual Meeting: Risk Management in Combination Products and Co-Packaged Kits
From post-aging performance testing to container closure integrity, robust design controls extend far beyond “constituent part” requirements. With the increase in complexity...
4 Things You Need to Know About Combination Drug Compliance
white paper 4 Things You Need to Know About Combination Drug Compliance Combination products are a fascinating area of the pharmaceutical industry and present great future...
Combination Products Challenge Regulators and Manufacturers
Combination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen,...
5 Critical Areas of Combination Drug Compliance
Combination drug products are complex to both develop and to manage from a compliance perspective. This presentation discusses five critical areas of combination drug...
