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Learn the differences in areas of expertise and responsibilities between the Clinical Supply Manager, Project Manager and Financial Project Analyst.
The current understanding among sponsors of the workflow from cell collection, to manufacturing, and to the clinical site for patient administration.
New anti-counterfeit technology, called a cyber-physical watermark, leverages edible fluorescent silk to identify medications.
The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
Telstar launches Usifroid global service platform for retrofitting & maintenance of freeze-dryers. To optimise and extend the life cycle of freeze-drying equipment from any brand or model.
In this in-depth focus experts describe the development of an effervescent multivitamin formulation stable enough for direct compression tableting and how packaging could benefit big pharma.
What lies ahead in the regulatory pipeline for medical device manufacturers? A compliance strategy to meet the 2023 Class II deadline
Here, Kallik’s Bob Tilling discusses the importance of acting early and embracing technology to comply with EU MDR labelling requirements, citing challenges from the recent scramble by many Class III medical device manufacturers to meet their May 2021 deadline.
Size matters – particularly in competitive markets such as pharma and nutraceuticals due to its direct result on costs. Tradichems patented Hipering® process begins right at the start of the process chain by miniaturizing the ingredients. Thanks to Piab’s piFLOW®p vacuum conveyor their patented process is continuously fed thus maintaining…
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
Susan Gosnell, product manager at NiceLabel, explores the potential labelling compliance issues for small medical device manufacturers and discusses how cloud labelling solutions could help combat them.
A framework to enable a holistic approach to CCI that assures both primary packaging and process contribute to good CCI of sterile vial product.
22 March 2021 | By Bruker Biospin Group
In this virtual roundtable, experts explore the uses of nuclear magnetic resonance (NMR) in the analysis of biologics and biosimilars and discuss how recent advances are changing the game.
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.