David Brett, Vetter Pharma International GmbH||June 2, 2016
For pharmaceutical companies both large and small, the challenges involved in developing new drugs are growing steadily. Regulatory requirements are becoming more complex, and the processes involved have followed suit. Even more innovative manufactur…
B.D. Naumann, P.J. Nigro, U. Bruen, L. Parola, D. Cragin and A. Schatz, Merck & Co., Inc. and Ashland, Inc.||May 5, 2016
Health-based exposure limits are needed to support risk assessments
Steve Haswell, 3M Drug Delivery Systems||May 5, 2016
An approach to process development of pMDIs using cold fill and pressure fill technology
Christian Fortunel, LZ Lifescience ||May 5, 2016
The challenge of implementing MES technology with increased regulation
Dr. Mike Long, ValSource||March 9, 2016
Background, thoughts and the current industry dialogue on FDA’s quality metrics initiative
Tim Wright, Editor||January 28, 2016
On the pulse of the pharmaceutical manufacturing value chain, DCAT Week ‘16 will deliver top-flight education programs and networking events.
Peter H. Calcott , Calcott Consulting LLC ||October 7, 2015
Has it changed since the issuance of the FDA and EMA guidances?
Suhasini Sharma, Sciformix Corporation ||September 11, 2015
Global biologics market will expand to $250 billion annually by 2020, with biosimilars and non-original biologics commanding 4-10% of that market
James Menoutis, Quantex Laboratories Inc. ||September 11, 2015
Where we were then, where we are now, and where are we going?
Lynn King, TKL Research||June 2, 2015
Implementing an acceptable clinical monitoring plan requires a thorough understanding of the new rules under which we’re operating
Chip Meyers and Robin Hooker, UPS||June 2, 2015
Leveraging industry best practices to protect consumer safety
Stephen W. Simco , Sedlak Management Consultants, Inc. ||March 6, 2015
With the fabric of healthcare distribution in flux, the challenge for pharmaceutical distribution executives is focused on how to leverage distribution infrastructure to reduce costs, but maintain the flexibility needed to mitigate risk across the supply chain.
Dr. Enrico T. Polastro , Arthur D. Little||January 29, 2015
Captive and merchant demand estimated at $80 billion and growing 4-5% per annum.
James Streeter, Senior Director, Oracle Health Sciences||January 29, 2015
Reducing the cost of clinical trials likely tops the list of New Year resolutions for many health sciences organizations.
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