Compliance
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Breaking News | Industry News | Information Technology | Validation
Gene Therapy Co. Selects ValGenesis' SaaS Platform
VLMS to digitize Its global validation programs.Contract Pharma Staff 01.06.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Collaborations & Alliances | Industry News | Information Technology | QA/QC
CDMO Cognate BioServices Teams Up with L7 Informatics
To implement L7|ESP for integrated manufacturing and lab operations.Contract Pharma Staff 12.16.20
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Bio News | Breaking News | Collaborations & Alliances | Industry News | Information Technology | QA/QC
Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management
CDMO is managing quality processes and content for greater visibility and compliance across global manufacturing.Contract Pharma Staff 12.16.20
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Breaking News | Facilities | Industry News | QA/QC
The Wasdell Group Earns ISO 13485 Certification
The newly certified facility will provide a base for PPFL services in Ireland.Contract Pharma Staff 12.14.20
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Breaking News | cGMP Manufacture | Industry News | QA/QC | Validation
UK’s VMIC to Implement Lonza’s MODA-EM
To digitize its Microbiology Quality Control operations.Contract Pharma Staff 12.08.20
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Capsules | Formulation Development | Methods Development | Process Development | Validation
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Biologics, Proteins, Vaccines | Inspections | Supply Chain
Inspecting the Unexpected
Preparing quality control processes for COVID-19 vaccine candidates.Dr. Andrea Sardella and Raffaele Pace, Stevanato Group 11.17.20
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APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs
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Validation
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Breaking News | Facilities | Industry News | QA/QC
Wuxi Griffin Completes Investment in New QC Lab and Storage Facility
Offers fully equipped microbiology and analytical testing lab for bulk and final product testing.Contract Pharma Staff 10.26.20
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QA/QC | Regulatory Affairs
Regulatory Compliance Trends
Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.Steve Cottrell, President, Maetrics 10.14.20
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Breaking News | Industry News | Inspections
Symbiosis Completes MHRA Regulatory Inspection
Scottish CMO recorded no critical or major observations from the reinspection by the MHRA.Contract Pharma Staff 10.13.20
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Breaking News | cGMP Manufacture | Industry News | Parenterals | QA/QC
Lonza Expands QC Testing Portfolio
Launches PyroCell MAT System for in vitro Pyrogen testing to help ensure safety of parenteral pharmaceuticals during development, manufacture and release.Contract Pharma Staff 10.01.20
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Biologics, Proteins, Vaccines | Regulatory Affairs
Ensuring Manufacturing Continuity for Essential Medicines
Applying the principles of Quality Risk Management to get medicines to market faster.John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20
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Inspections
Virtual Site Audits Should Be the New Standard
Discovering the value of virtual site audits during the COVID-19 crisis.Jeannie Metzinger, PCI Pharma Services 09.09.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Managing Editor 09.09.20
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Aseptic Processing | Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Regulatory Affairs
LSNE Expands Aseptic Fill Finish Capabilities in Europe
LSNE-León receives approval from AEMPS to manufacture biotechnology-based therapeutic products.Contract Pharma Staff 08.28.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Online Exclusives Kristin Brooks, Contract Pharma 08.25.20
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Breaking News | Facilities | Industry News | Inspections
FDA Approves Romark Facility in Puerto Rico
The facility is equipped to produce tablets, powders and other oral solid dosage forms.Contract Pharma Staff 08.24.20
