About
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Launched in September 2007 and written for the pharmaceutical regulatory community including regulators, academia, consultants and attorneys. Covers regulatory issues for pharmaceutical and biotech products including the areas of CMC and GMP. Specially covers the relevant issues surrounding international harmonization and helps to further the discussion about the regulatory approaches appropriate for advancing products and processes. Each issue provides an in-depth analysis of a problem area and developing regulatory initiative. Seeks to improve understanding of issues and aid the development of harmonized global regulation of pharmaceutical quality and corporate quality systems. Also reports on the key conferences and workshops where proposals for industry and regulatory guidances and initiatives are being presented and covers the US Food and Drug Administration (FDA). Includes information on international quality initiatives and harmonization efforts involving industry associations, regulatory agencies, pharmacopeias and standard-setting organizations around the globe.
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United States of America
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Pharmaceutical Manufacturers, Pharmaceuticals, Biotechnology
Bio
Launched in September 2007 and written for the pharmaceutical regulatory community including regulators, academia, consultants and attorneys. Covers regulatory issues for pharmaceutical and biotech products including the areas of CMC and GMP. Specially covers the relevant issues surrounding international harmonization and helps to further the discussion about the regulatory approaches appropriate for advancing products and processes. Each issue provides an in-depth analysis of a problem area and developing regulatory initiative. Seeks to improve understanding of issues and aid the development of harmonized global regulation of pharmaceutical quality and corporate quality systems. Also reports on the key conferences and workshops where proposals for industry and regulatory guidances and initiatives are being presented and covers the US Food and Drug Administration (FDA). Includes information on international quality initiatives and harmonization efforts involving industry associations, regulatory agencies, pharmacopeias and standard-setting organizations around the globe.
Website
Social media
Location
Frequency
Circulation
Sectors
Pharmaceutical Manufacturers, Pharmaceuticals, Biotechnology
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