Compliance
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GMPs/GCPs
What are GMPs?
And why do we need them in contract work?Emil W. Ciurczak, DoraMaxx Consulting 09.06.17
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Regulatory Affairs
FDARA and Beyond
In a few short years, PBOA establishes itself as a key industry resourceGil Roth, Pharma & Biopharma Outsourcing Association 09.06.17
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Regulatory Affairs | Supply Chain
Supply Chain Risk Mitigation
Addressing the inherent risks in an increasingly fragmented supply chainNuala Calnan, Lachman Consultant Services 09.06.17
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QA/QC
FDA & OTC Antiseptics
A review of consumer antiseptic wash ingredients undergoing FDA challengeDerek J. Prince, Herbert N. Prince & Daniel L. Prince, Gibraltar Laboratories 09.06.17
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GMPs/GCPs
The Importance of GMP, GLP and GCP in the Safe Development of Viral Challenge Agents
Developing new challenge agents faster and at a lower cost.Adrian Wildfire, Clinical Research 09.06.17
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Regulatory Affairs | Serialization
The DSCSA Delay What Does it Mean for the Pharma Industry?
What should companies be doing to implement a suitable serialization solution before the new enforcement date arrives?Erik Haeffler, Recipharm 09.06.17
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Regulatory Affairs
Data Integrity: A Practical and Risk-Based Approach
Ways an organization can form a culture and cost-effective means to meet the various challenges in sustaining data integrity.Robert Marohn, ClinLogic 09.06.17
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Regulatory Affairs | Serialization
The Psychology of DSCSA: Four Stages of Serialization
It’s time for manufacturers to adopt post-serialization efficiencies.Larry Hotz, Marketing Manager, WDPrx - Woodfield Pharmaceutical LLC 09.06.17
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Regulatory Affairs | Serialization
Fighting Back!
The drug industry takes a bare-knuckle approach to drug counterfeiters.Daniela Geiger, Vetter 09.06.17
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Regulatory Affairs | Serialization
Serialization Validation: Right Fitting Your Strategy With a CMO
There are three key factors for manufacturers to evaluate as they define and refine their validation and testing approach.Linda Kristoffersen and David Colombo, KPMG Life Science Advisors 09.01.17
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Breaking News | Industry News | QA/QC | Risk Management
Sanofi to Transform its Contracting Foundation
Selects Icertis’ digital platform for cloud management09.01.17
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cGMP Manufacture | Industry News | Regulatory Affairs
FDA Releases FY 2018 GDUFA Rates
The FY 2018 fee represents a significant drop from FY17's FDF fee of $258,64608.28.17
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Breaking News | Industry News | Inspections
CordenPharma Latina US-FDA Warning Letter Closed
Closeout date was August 15 for the Italy facility08.24.17
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Breaking News | Industry News | QA/QC
QPharma Expands Footprint with Somerset-area Office
New central location will enhance solutions and services08.18.17
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Industry News | Inspections
Valeant's Tampa Facility Receives FDA VAI Classification
Following collaboration with FDA, issues related to a cGMP inspection are being resolved08.17.17
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Breaking News | Facilities | Industry News | Inspections
Aerie Pharma’s CMO Receives FDA CRL
Was issued in response to CGMP inspection at Tampa facility08.10.17
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Industry News | Regulatory Affairs
Cingulate, Camargo Enter Regulatory Consulting Agreement
To provide regulatory consulting and strategic development services for two ADHD drugs08.08.17
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Breaking News | Industry News | Regulatory Affairs
FDA Approves CMP Pharma’s CaroSpir
Spironolactone oral suspension is the only FDA-approved oral liquid dosage form of its kind08.07.17
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Breaking News | cGMP Manufacture | Industry News | Regulatory Affairs
Senate Passes FDA Reauthorization Act
Aims to allow faster approval of generic drugs and modifies fee structure for various stakeholders08.04.17
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Industry News | Inspections
Envigo Site Recertified to New ISO Standard
ISO9001:2015 revision has re-focused on performance by combining the process approach with risk-based thinking07.28.17
