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At the heart of every drug lies one or more active pharmaceutical ingredients (APIs). While the phrase “regulatory affairs” typically conjures thoughts of FDA approvals of finished-dose drugs, regulatory matters…
Many companies dread FDA quality audits…even when they’ve invested the preparation, long-term vigilance and dedication to quality to make them a success. The growing number of pharma and biotech firms…
We’re so excited! Neuland Labs just received a huge award – the 2013 CMO Leadership Award in the Regulatory category from Life Science Leader magazine. It’s an honor to have…
With research becoming highly-specialized, many companies are turning to CROs with particular skill-sets – especially in complex chemistry. For us at Neuland, companies tend to be looking for method development…
I’ve written before about the incredible speed of the Pharma industry’s growth in India, and the future outlook continues to look very bright. While the Indian pharma market is facing…
Outsourcing to a contract manufacturer these days means more than just having your product manufactured and drop-shipped. But what – exactly – are today’s pharma companies expecting from their manufacturing…
For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…
