November 4, 2021
Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.
November 1, 2021
Mike Carroll, Quality Professional and Aseptic Processing specialist has an extensive history in microbiology and pharmaceuticals. One of his most recent commentaries is on Microbiological Quality Considerations in Non-Sterile Drug Manufacturing, a draft of guidance published in September of 2021
October 7, 2021
When you’re developing and manufacturing your active pharmaceutical ingredients, the last thing you want to deal with is surprises. Unfortunately, even with the soundest methods, processes, and strategies, problems occur in manufacturing.
September 16, 2021
Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).
September 2, 2021
DSI has seen a lot of pharmaceutical development reports ranging from several hundred pages to a summary of conclusions attached to stacks of data. The latter can make things difficult when it’s time to put a regulatory filing together. It’s become clear that capturing development decisions and data from the outset in a living document is good practice and whether the data collected thus far is supporting development goals. It’s a reference point for what has been completed and what still has to be done.
August 19, 2021
As sponsors have started to shift more and more of their manufacturing to outsourcing partners, relationship building has become an even greater priority. This is where the person-in-plant becomes an invaluable source for building a more trusting relationship with the contract research manufacturer (CMO). Essentially, a person-in-plant is a sponsor employee or, more often, a third-party expert consultant who is present at the contract manufacturing site to observe, support, and provide feedback to all stakeholders.
