Regulatory/GMP Compliance

Sep 09, 2013
By Pharmaceutical Technology Editors
Draft guidance recommends in-vitro and in-vivo studies to establish bioequivalence.
Sep 07, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Video recorded at Validation Week Canada
Sep 04, 2013
By Pharmaceutical Technology Editors
Prequalification of Sanofi Pasteur?s Menomune vaccine makes it eligible for purchase by United Nations agencies.
Sep 02, 2013
Pharmaceutical Technology
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Sep 02, 2013
Pharmaceutical Technology
New FDA supply chain policies aim to strengthen inspection and oversight processes.
Aug 28, 2013
Pharmaceutical Technology
By Pharmaceutical Technology Editors
Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.
Aug 28, 2013
By Pharmaceutical Technology Editors
FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.
Aug 14, 2013
By Pharmaceutical Technology Editors
CDER withdraws some outdated guidance documents and makes plans to finalize others.
Aug 07, 2013
By Pharmaceutical Technology Editors
The guidance describes a risk-based approach to monitoring of clinical trials.
Jul 02, 2013
By Pharmaceutical Technology Editors
Falsified Medicines Directive requires imported APIs to have written confirmation of GMP standards.
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