Compliance
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Bio News | Industry News | Promotions & Moves | Regulatory Affairs
Former FDA Senior Executives Join PAREXEL
The industry veterans will work on the company's Regulatory Consulting group02.15.19
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Breaking News | Industry News | Information Technology | Inspections | QA/QC | Regulatory Affairs | Validation
Top Global Pharma Company to Implement ValGenesis' VLMS
Paperless validation system aims to harmonize and standardize the validation process across all its global sites02.12.19
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Breaking News | Clinical Trials | Industry News | QA/QC
WCG, Prudentia Enter Pharmacovigilance Alliance
Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development01.29.19
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Bio News | Collaborations & Alliances | Industry News | Validation
ValGenesis VLMS Chosen to Digitize Validation Process
New Jersey-based leading contract manufacturer of pharmaceutical drugs chooses company's 100% paperless VLMS01.29.19
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Regulatory Affairs | Serialization
Serialization Compliance: Understanding the Challenges
Pharmaceutical Industry Trails Behind on Serialization for DSCSA.Peter F. Sturtevant, Senior Director, Industry Engagement – Pharmaceuticals, GS1 US 01.25.19
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Bio News | Facilities | Industry News | Regulatory Affairs
Wasdell Granted HPRA for New HQ
Now certified to conduct qualified person (QP) batch certification and release of pharmaceutical products to Europe01.24.19
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Breaking News | cGMP Manufacture | Clinical Trial Materials | Industry News | Inspections
Upperton Pharma’s Nottingham Site Passes MHRA Inspection
Gains licenses for manufacture, downstream processing into capsules and tablets, as well as spray dried formulations of biotherapeutics and small molecule APIs01.16.19
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cGMP Manufacture | Clinical Trial Materials | Drug Development | Drug Discovery | Regulatory Affairs
CDMO Outsourcing Trends
iBio’s R. Barry Holtz discusses the trends driving R&D and outsourcing, as well as some of the biggest opportunities for CDMOsOnline Exclusives Kristin Brooks, Contract Pharma 01.11.19
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Breaking News | Industry News | Inspections
Akorn Receives FDA Warning Letter
Akorn is working collaboratively with the FDA to resolve all issues related to an inspection of its Decatur, IL manufacturing facility01.09.19
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Analytical Services | Bio News | Bioanalytical Services | Breaking News | Industry News | Information Technology | Logistics | R&D | Supply Chain | Validation
Blockchain Technology: How Much Money Will It Save?
GlobalBlock Co-Founder, David Thomas, shares insight about the future of Blockchain Technology in the Pharmaceutical industryOnline Exclusives Betsy Louda, Associate Editor 01.08.19
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QA/QC
Three Ways Quality Can Impact a Business’s Bottom Line
The Quality function today is tasked with helping to improve overall company performanceStephen McCarthy, Vice President of Digital Innovation at Sparta Systems 12.05.18
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Cleaning Validation | Validation
Compliance Insight, Inc.
Compliance Insight, Inc. specializes in hands-on FDA Regulatory and Quality Assurance consulting and training for the pharmaceutical, dietary supplement, medical device, chemical, cosmetics, bio-technology and food industries worldwide. Services incl…Cindy Ipach, President 11.28.18
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Clinical Trials | Drug Development | GMPs/GCPs | Information Technology
Update on ICH E6 R2 Guideline for GCP
Patrick Hughes of CluePoints discusses opportunities and advantages of the new guidance and considers possible limitationsPatrick Hughes, Chief Commercial Officer, CluePoints 11.27.18
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Chemistry | Methods Development | Microbiology | Validation
Pace Analytical Life Sciences, LLC
Pace Analytical Life Sciences is a full service contract analytical testing laboratory providing chemistry and microbiology testing services to the pharmaceutical and medical device industries. Services include methods development/validation, raw mat…James Wheeler, james.wheeler@pacelabs.com 11.21.18
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APIs | Breaking News | Facilities | Industry News | Inspections
CordenPharma Completes SafeBridge Recertification
Potent Compound Recertification Audit was conducted at Colorado site11.20.18
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APIs | Serialization | Validation
ATL - Ad Tape & Label
ATL, a 60 year old company, specializes in custom labels and the manufacturing and packaging of die cut disposable components for the medical and pharmaceutical industry. Label capabilities include single-ply, extended content, and multi-panel bookle…Gina Butler, Marketing Manager 11.16.18
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APIs | Process Development | Validation
Rommelag CMO - Holopack Verpackungstechnik GmbH
Rommelag CMO provides you with quick and easy access to BFS technology without having to invest in either the mandatory GMP environment that goes with it or the specialists required to operate and maintain the machines. What we offer is the whole spe…Andreas Haeussner, Director Marketing 11.15.18
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Process Development | Validation
Rommelag CMO - Maropack AG
Holopack Verpackungstechnik GmbH as well as maropack ag are members of the Hansen-Group, the inventor of the bottelpack aseptic filling machines based on the Blow-Fill-Seal (BFS) technology. We offer secure, economical and individualized solutions fo…Andreas Haeussner, Director Marketing 11.15.18
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Capsules | Supply Chain | Validation
Pharma Tech Industries
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QA/QC | Serialization | Supply Chain
Don’t Just Tick the Box, Think Outside Of It
How a quality-first approach to serialization can deliver long-term value beyond compliance.Martin Van Trieste, CEO, Civica Rx and Board Member, rfxcel 11.13.18
