The past few years have seen major changes to the ways in which drug companies and their regulators go about ensuring the safety and efficacy of drugs. The response to…
Pharmaceutical process chemistry has come a long way since wholesale merchants began the commercial marketing of drugs in the 19th century. In fact, process chemistry has driven many of the…
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…
In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…
Supply chain management is an essential chapter in the pharmaceutical manufacturing handbook. Managing regulatory starting materials (RSMs) seeks to maximize commercialization and sustainability while meeting and/or exceeding regulatory requirements. Drugmakers…
Green initiatives may be slowly gaining some traction across the pharmaceutical industry, but there is still a long way to go. These are some astonishing insights from sciencehistory.org. “On a waste-to-product…
Drug development is exciting. There’s no getting around it: being a part of an industry which aims to improve human health is a great motivator for waking up and heading…
Scientific breakthroughs in the pharmaceutical industry can happen overnight, but it still takes time to perfect a discovery’s applications. Deuterium-labeled active pharmaceutical ingredients (APIs) are one specific advancement that has…
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…
When a drug transitions from early-stage development to late-stage development, the drugmaker has some big decisions to make. Chief among them: Who are they going to work with to move…