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As a follow-up to our recent two-part series on Regulatory Starting Materials Sourcing & Supplier Management, we sat down with Senior Vice President of Supply Chain Management at Neuland Labs…
There’s a growing consensus in the pharmaceutical industry that drug makers should embrace green chemistry. The last decade of pharma manufacturing has seen green chemistry practices shift from aspirational stewardship…
The idea of gaining – and maintaining – adequate process control during drug synthesis isn’t new. It underscores the entire point of approaches such as Quality by Design (QbD), and…
Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…
Supply chain security has been the subject of numerous posts on this blog in the past. It is important to note, however, that the pandemic hasn’t widely impacted global supply…
Facility inspections continue to be on the minds of both drug manufacturers and regulators. Over the past year, we’ve discussed the challenges surrounding inspections in our Maintaining Quality and Supply…
During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…
Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…
The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…
Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…
