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With potential projected losses of $16-32 billion for drugs going off-patent in 2015, intellectual property (IP) is increasingly crucial to keeping a competitive edge in the pharmaceutical and biotechnology markets….
The continued growth of virtual pharma – and the subsequent rise of virtual biotech – have made a lasting impression on the pharmaceutical contract manufacturing industry. Big Pharma firms, some…
There have been a number of articles recently pointing to growth in the API industry, and it’s something I’ve discussed as well – most recently in a post on the…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
I’ve mentioned the importance of route scouting in the past. Now I’d like to share some of the properties of API synthesis that can affect the yield, purity, and delivery date…
In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…
It’s been nearly two years since the FDA issued their draft guidance on quality agreements and contract manufacturer management. The consensus seems to be that the FDA shifted the responsibility…
We announced in late January that Neuland will be receiving a CMO Leadership Award for the third consecutive year – this time in the Quality category. This follows another recent…
Neuland has taken more than 300 processes from gram to commercial scale. We’ve filed 400 DMFs worldwide for 60 APIs. We have more than 400 clients in 80 countries, and…
Let’s face it – ‘cost-effective capabilities’ is a big reason why CROs and CMOs continue to be a highly-popular drug commercialization route of choice. Where else can you find ready-to-go…
