Search Results for 'cgmp compliance'
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cGMP Manufacture | GMPs/GCPs | Inspections | Regulatory Affairs
FDA cGMP Inspections Amid COVID-19 Pandemic
Despite FDA's postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops.John J. Carney, Lee H. Rosebush, Susrut A. Carpenter, Andrew M. Serrao, BakerHostetler 04.22.20
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Bio News | Breaking News | Facilities | Industry News
Akron Biotech Expands to Second US Manufacturing Facility
New site in Sarasota, FL, increases manufacturing capacity for cell and gene therapy materials and technologies04.01.20
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Breaking News | CRO News | Promotions & Moves
Parexel Adds Experts to Regulatory Consulting Group
Four new hires from U.S. FDA and MHRA will serve as technical vice presidents12.10.19
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cGMP Manufacture | Facilities
Transitioning from Clinical Production to Commercial Manufacturing
Cell and gene therapy facilities face a unique set of challenges as they scale towards commercial production and require equally unique solutions.Peter Walters, Lead Process Engineer, CRB USA 11.20.19
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Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Scale-up/Technology Transfer
The Pain-Free Guide: Transitioning from Clinical Production to Commercial Manufacturing
Cell and gene therapy facilities face a unique set of challenges as they scale towards commercial production and require equally unique solutionsPeter Walters , Lead Process Engineer, CRB USA 11.11.19
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Pricing Headwinds
Generic firms see red; CDMOs stay resilientOnline Exclusives S Harachand, Contributing Editor 07.17.19
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Biologics, Proteins, Vaccines
Outsourcing in China: How far can it go?
China’s biopharmaceutical services market is on pace to top $1 billion by 2021Vicky Qing Xia, BioPlan Associates 07.15.19
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Bio News | Breaking News | cGMP Manufacture | Facilities | Industry News | Inspections
Cytovance Completes Second FDA PAI of Oklahoma Facilities
Demonstrates capabilities and cGMP compliance in manufacturing commercial products06.18.19
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Nutraceutical Brands Find Relief in Outsourcing Manufacturing
More companies are working with contract manufacturers to manage resources and focus on business development.Sean Moloughney, Editor, Nutraceuticals World 03.06.19
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Bio News | cGMP Manufacture | Facilities | Industry News | Inspections
GRAM Completes Successful FDA Inspection
Following eight day inspection, GRAM was found to be in compliance with cGMP, with no Form 483 observations issued11.09.18
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Aseptic Processing | Bio News | Breaking News | Facilities | Industry News
IPS to Provide Engineering Solutions for Althea's New Mfg. Facility
Althea recently expanded operations to include manufacturing of highly potent drug products as well as ADCs09.14.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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Industry News | Promotions & Moves
Metrics Names Associate Director of Pharma Development
Yogesh Sadhale to manage all aspects of formulation development and manufacturing of a client’s clinical trial materials12.04.17
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Supply Chain
Secondary Packaging Trends
Pharma is leveraging packaging to address the challenge of patient adherenceRupert Taylor 11.07.17
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Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News
Acasti Pharma and CordenPharma Team Up
Announce large-scale production of CaPre with new continuous manufacturing process06.07.17
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Regulatory Affairs
Challenges and Advantages of International Regulatory Inspections
A look at the processes and approaches followed by FDADaniel Barreto, Lachman Consultants 03.07.17
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Drug Discovery | Promotions & Moves
AMRI Adds Quality and Compliance Role
Yu to oversee quality and cGMP compliance in all divisions05.10.16
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