Government
PRODUCTS
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![503B drug compounding]( "Cleanrooms And Equipment For 503B Outsourcing Facilities")
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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![GettyImages-917590578 Code of Federal Regulations (CFR)]( "Electronic Batch Records (EBR) Software For Drug Manufacturing")
Ensure compliance and improve efficiency by automating your paper-based systems with an integrated EBR system, like MasterControl Manufacturing Excellence.
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![GettyImages-1480979249-consulting-office-computer-windows]( "Manufacturing Execution System Consulting Services")
We support you in the process of optimally implementing complex Manufacturing Execution Systems. In addition to the creation of Master Batch Records (MBRs) and Electronic Batch Recording (EBR), including classic data acquisition and preparation, as well as all other processes that have immediate effects on the manufacturing process.
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![Global networking healthcare-GettyImages-1477437266]( "Global Contact Center Services")
Best-in-class contact centers serving life science organizations 24/7/365.
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![Germfree - compounding operations]( "Panels For Compounding Operations And Critical Environments")
The healthcare industry demands durable, cleanable, and safe environments. Arcoplast offers a comprehensive solution for critical areas like operating rooms, cleanrooms, and compounding pharmacies.
WHITE PAPERS AND CASE STUDIES
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![GettyImages-1206365639 consent]( "Patient Insights Informed Consent Engagement")
Patient Insights Informed Consent EngagementBy incorporating the patient viewpoint throughout the informed consent process, discover how this technical solution enhanced the overall patient experience within clinical research operations.
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![ripple-effect]( "The Ripple Effect: A Digitalization Playbook")
The Ripple Effect: A Digitalization PlaybookAs the water sector takes on the escalating challenges of accessibility, affordability, and resilience against climate change, digital solutions have demonstrated the potential to transform water systems.
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![GettyImages-1468153601-regulation-honeycomb-hand-target]( "Guide To Navigating The Complex And Expanding Regulatory Landscape")
Guide To Navigating The Complex And Expanding Regulatory LandscapeIn today’s complex landscape, organizations face growing compliance demands from diverse sources. Learn how a strong compliance system and culture of accountability drive sustainable growth and protect long-term success.
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![Gene Therapy GettyImages-1164556175]( "Advancing Cell And Gene Therapy Clinical Development In 2023")
Advancing Cell And Gene Therapy Clinical Development In 2023Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
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![India Flag]( "Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection")
Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data CollectionExplore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.
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![Checklist GettyImages-1341698174]( "Top 11 Considerations For Employing A Managed Service Model")
Top 11 Considerations For Employing A Managed Service ModelIn today’s marketplace, it is becoming more attractive for companies to hire out non-differentiating capabilities. Explore 11 key considerations when taking advantage of the high value managed service marketplace.
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![GettyImages-1460220646-dashboard-system]( "Incremental Adoption Of A Modular Operations Platform")
Incremental Adoption Of A Modular Operations PlatformDiscover the potential of a modular operations platform that scales the benefits of digitalization and aids organizations in implementing a unified data strategy to realize the full potential of smart manufacturing.
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![CRO Selection Taken Seriously]( "How The Fast-Changing R&D Pipeline Is Amplifying The Importance Of Adaptable CROs")
How The Fast-Changing R&D Pipeline Is Amplifying The Importance Of Adaptable CROsFind out how major advances in the understanding of the causes of once-untreatable diseases have reshaped the global drug development pipeline over the past decade, paving the way for better health outcomes for many millions of people.
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![GettyImages-1270410318 machine mapping]( "Leveraging Machine-Learning For SDTM Mapping")
Leveraging Machine-Learning For SDTM MappingThe Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) represents trial data in a standardized format for review, but could its preparation be automated?
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![European flags-GettyImages-139491451]( "Revolution In The EU Pharmaceutical Legislation Ahead")
Revolution In The EU Pharmaceutical Legislation AheadDiscover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.
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![GettyImages-2157700365-quality-audit-clipboard-paper-writing-pen]( "Best Practices For Internal Quality Audits In Life Sciences")
Best Practices For Internal Quality Audits In Life SciencesDiscover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.
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![GettyImages-1398578847-check-list-check-mark-circle-document-hand-pen]( "4 Steps To Understanding The Quality Journey")
4 Steps To Understanding The Quality JourneyExplore a four-step framework for organizations to enhance quality management, emphasizing its importance in driving business success, customer satisfaction, and competitive advantage.
NEWS
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Crest Infosolutions Expands Operations In Indonesia, Offering Alfresco ECM And BPM Solutions For Diverse Sectors7/30/2024
Crest Infosolutions, a premier Hyland Alfresco Partner, is excited to announce the expansion of its operations in Indonesia.
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City Of Paso Robles, CA, Poised To Elevate Asset Management With OpenGov1/5/2024
Looking for a way to eliminate paper-based processes and establish a unified system for task tracking and reporting, the City of Paso Robles was on the hunt for a new system.
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CMC, COMECARNE & Meat Institute Sign Joint Statement Of Coordination2/20/2024
To deepen meat industry coordination and government collaboration in Canada, Mexico and the United States, the Canadian Meat Council (CMC), Consejo Mexicano de la Carne (COMECARNE), and the Meat Institute signed a Memorandum of Understanding (MOU) that formalizes the three associations’ ongoing work to improve trade, reduce regulatory barriers and enhance information exchange within North America.
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Scaling Aflasafe: From Lab-Based Innovation To Large-Scale Aflatoxin Mitigation Across Africa2/24/2025
Aflatoxin contamination remains a major challenge in sub-Saharan Africa (SSA), threatening food and feed safety, public health, and trade.
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Paperless Innovations' Solutions Now Available On Carahsoft's GSA Schedule And Additional Contract Vehicles2/22/2024
Paperless Innovations, Inc., the leading provider of government purchase card (GPC) compliance automation solutions, and Carahsoft Technology Corp., the Trusted Government IT Solutions Provider®, today announced that Carahsoft has added Paperless Innovations’ GPC compliance automation products to its GSA Schedule.