Regulatory/GMP Compliance

Feb 02, 2018
Pharmaceutical Technology
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.
Feb 02, 2018
Pharmaceutical Technology
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
Feb 02, 2018
Pharmaceutical Technology
This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.
Feb 02, 2018
Pharmaceutical Technology
Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.
Feb 01, 2018
Pharmaceutical Technology
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
Feb 01, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.
Jan 26, 2018
Pharmaceutical Technology's In the Lab eNewsletter
By Pharmaceutical Technology Editors
The Fluent Gx Automation Workstation from Tecan is suited for a variety of clinical and regulated laboratory applications.
Jan 24, 2018
By Pharmaceutical Technology Editors
The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.
Jan 23, 2018
By Pharmaceutical Technology Editors
The FDA center released its list of planned guidance documents for the rest of the year.
Jan 23, 2018
By Pharmaceutical Technology Editors
The latest continuing resolution funds the government for three weeks.
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