Document Migration
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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Several of our recent Life Sciences podcasts have featured conversations about the rapid shifts taking place in this dynamic industry. Automation and information management technology are rapidly advancing to help address these challenges.
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Altasciences’ experienced team specializes in early-phase renal and hepatic impairment studies, delivering tailored clinical pharmacology trials that support your regulatory submissions.
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Enforce standardized workflows while collecting data in real time, giving you the visibility you need to prevent deviations, review exceptions, and release batches faster.
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From product development to translation into clinical trials, GTx’s clinically validated scalable electroporation technology is equipped to handle your most complex cellular engineering demands.
- Rapidly transfect from 75 thousand to 20 billion cells
- Move forward with 21 CFR Part 11 enabled software
- Develop quickly with an established regulatory path supported by a FDA Master File
- Manufacture confidently with closed, cGMP-compliant, ISO-certified and CE-marked products
- Enjoy MaxCyte’s proprietary Flow Electroporation® technology
WHITE PAPERS AND CASE STUDIES
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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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Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
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Boosting CMC Regulatory Efficiency In Gene Therapy
Ensure your business stays ahead in today’s complex regulatory environment by implementing robust regulatory affairs strategies that streamline compliance and product approvals.
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Providing Enhanced Manufacturing Data To Contracting Companies
The life sciences sector is projected to reach $220 billion by 2030. Examine the growth of CDMOs and CMOs, emphasizing the need for digitalization to meet client demands and regulatory standards.
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Revolution In The EU Pharmaceutical Legislation Ahead
Discover 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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ProPharma Supports A Contract Manufacturer's Form 483 Response
Learn how a small contract manufacturer navigated a complex FDA 483 Observation notice and implemented effective remediation strategies that addressed multiple system-wide concerns.
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Development And Optimization Of Suspension-Adapted 293T Cell Line
Learn how an adapted cell line can reduce costs and improve scalability in the production of lentiviral vectors for CGTs and examine its potential to produce GMP-grade lentiviral vectors.
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Using eConsent Data To Populate Site And Sponsor Data Systems
A top-10 pharmaceutical company was looking to reduce the amount of administrative burden on their clinical trial sites and themselves. See how we accomplished it, using eConsent.
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Revolutionizing Biofilm Research: High-Resolution, Real-Time Imaging with ZeGage Optical Profiler
A university lab optimized biofilm research with Zygo’s ZeGage Optical Profiler, enabling high-resolution, real-time, non-contact imaging that accelerates data collection, enhances accuracy, and preserves biofilm integrity.
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Achieving Titer Increase Up To 4-Fold While Maintaining Product Quality
Discover customizable solutions for antibody manufacturing, as well as services for media optimization, feeding strategy optimization, and format conversion.
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OEE And Product Inspection
Explore the calculation of Overall Equipment Effectiveness (OEE) and the impact of product inspection equipment on OEE in the pharmaceutical industry.
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Study Start-Up Challenges: Hard Realities, Effective Strategies
Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?
NEWS
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IDScan.net Expands Cloudbeds Integration Of ParseLink To Streamline Guest Check-In12/2/2025
IDScan.net, a leading provider of identity verification and ID scanning technology, today announced an expanded integration with Cloudbeds, the intelligent unified platform powering hotel growth.
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Wagga Livestock Agents Lead The Way In Sheep And Goat eID Rollout5/14/2025
The Wagga Wagga Livestock Marketing Centre (LMC) has taken a major step forward in the transition to electronic identification (eID) for sheep and goats, successfully scanning nearly 15,000 individual electronic identification devices during last months record sale.
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TechMatter Launches Cure AR, A Next-Gen AI-Enabled Medical Billing Software To Simplify Healthcare Revenue Management10/27/2025
TechMatter proudly announces its medical billing software, Cure AR.
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LogicalDOC 9.2.1 Now Available With Enhanced AI And Security Features10/7/2025
LogicalDOC, a leading provider of enterprise document management solutions, is proud to announce the release of LogicalDOC 9.2.1, a major update designed to deliver enhanced AI capabilities, stronger security, and even greater efficiency for organizations worldwide.
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Launch Of Fleetwaro.ai, The New Cloud-Based Fleet Platform For Intelligent, AI-Powered Fleet Management12/5/2025
Fleetwaro.ai is a cloud-based software for fleet management with the power of AI. It is designed for fleet managers who want to manage their vehicle fleets, regardless of size or industry, in a structured and cost-efficient way.