Ultra High-Volume Scanners
PRODUCTS
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Our RegOps team offers document-level publishing or management of the entire regulatory submission process. Coupled with our electronic document management system (Veeva), we can oversee all technical aspects for submission of your dossier (eg, eCTD document granularity, utilization of content templates, document formatting, hyperlinking, bookmarks, navigation, publishing, and redaction services).
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There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.
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Neither traditional nor hybrid clinical trials can operate on rigid EDC systems.
They require flexible data collection systems that support protocol amendments without downtime and accept mobile data without hassle. As a cloud-native solution, TrialKit bends to accommodate mid-study changes. And as the first full-featured EDC platform available as a native mobile app, TrialKit flexes to meet the demands of traditional, hybrid/decentralized, and completely remote clinical trials.
Give your team the freedom to build, deploy, and manage their studies, their way—weeks faster than with rigid EDCs and for a fraction of the cost of the major players.
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ÄKTA avant™ is a preparative chromatography system designed for fast and secure development of scalable methods and processes.
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The Vericheck ddPCR Empty-Full Capsid Kit enables a quick and precise measurement of the empty-full capsid ratio that is needed to produce AAV vectors.
WHITE PAPERS AND CASE STUDIES
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Streamlining AAV And LVV Manufacturing Platform Solutions
Observe how streamlined, scalable platforms are transforming viral vector manufacturing to accelerate the delivery of cell and gene therapies to patients.
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How A CDMO Gained 40%+ Efficiency By Generating Automated APQRs
Discover how a CDMO's mounting challenges with manual product quality review (PQR) processes were resolved through the implementation of a next-generation cloud-based solution.
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Compliance Auditing: Diving Into Common Critical Findings
Review critical findings in compliance audits, highlighting frequent issues, their impact on operations, and steps companies can take to improve regulatory compliance.
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Transforming Environmental Monitoring And Sample Management
Discover how applying an OpEx framework to environmental monitoring and sample management can optimize workflows, improve resource utilization, and deliver measurable annual cost savings.
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Streamlining Antibody Capture With Multi-Column Chromatography
Explore innovative solutions to overcome the limitations of traditional batch chromatography, improving efficiency, reducing costs, and optimizing production for complex biologics like monoclonal antibodies.
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Accelerating Approval Pathway For Phase III Ovarian Cancer Trial
A late-stage biotech developing a first-in-class therapy for a rare, chemo-resistant form of ovarian cancer sought help for accelerated FDA approval.
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Process Scale Column Packing Instructions
Explore a comprehensive guide to using DurA Cycle A50, a high-capacity, alkaline stable protein A affinity chromatography resin for the downstream processing of mAbs and recombinant proteins.
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Leaks Go Acoustic: How Rogers Water Reduced Waste And Built Resiliency
Read how Rogers Water Utility (RWU) took action to mitigate constant leaks in their distribution system, which made it challenging to maintain volume in the eastern district’s water tower.
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Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors
Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.
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Leeton Shire Improves Efficiency And Service Levels With An Affordable, Intuitive Digital Solution
Although Leeton Shire already had some digital technologies in place, such as SCADA, GIS and AMI, they lacked hydraulic modeling capabilities and expertise — which is why they turned to Qatium’s open and secure water management platform.
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The Savings Are Blowin' In At Port Washington Wastewater Treatment Plant
The municipal wastewater treatment plant in Port Washington, Wisconsin, is located on the picturesque shore of Lake Michigan, so it’s essential that their plant performs as designed.
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Rapid Results In A High-Stakes Dry Eye Disease Trial
This time-sensitive Phase 3 trial in dry eye disease required precision project management leveraging strong site relationships, ophthalmology-specific expertise, and data-driven site selection.
NEWS
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Coperion K-Tron Proud Supplier Of High Accuracy Batch Feeders To Pfizer Germany High Containment Facility3/11/2025
Pfizer, a global leader in the pharmaceutical industry, chose to integrate high accuracy Coperion K-Tron feeders into its new high containment manufacturing plant in Freiburg, Germany. This completely automated production facility is designed to maximize the efficiency and productivity of Pfizer's pharmaceutical production processes, doubling drug production capacity while shortening production times.
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Decimal Point Analytics Launches DocuAgentIQ - Agentic AI Platform Transforming Document Workflows In SBA & CRE Lending8/23/2025
Decimal Point Analytics today announced DocuAgentIQ, a purpose-built Agentic AI platform that modernizes document-heavy work across SBA and CRE lending.
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At IPPE, TekniPlex Consumer Products To Highlight New US Facility For Specialty Molded Fiber, And Its Range Of Sustainability-Minded Processor Trays1/10/2025
TekniPlex Consumer Products, a globally integrated provider of innovative solutions through materials science and manufacturing technologies, heads into IPPE 2025 on the heels of launching a 200,000-square-foot facility in Van Wert, Ohio, dedicated to the molded fiber solutions sector.
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PacBio Expands Partnership With seqWell To Bring Scalable Long Read Sample Prep To More Labs10/7/2025
PacBio (Nasdaq: PACB), a leading developer of high-quality, highly accurate sequencing solutions, today announced an expanded partnership with seqWell, a global provider of genomic library and multiplexing workflow solutions.