Document Migration
PRODUCTS
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Navigating both the specific country and general European regulations and requirements to supply medicinal products to the European markets can be a complex challenge. This applies both to Marketing Authorisation Holders (MAH) of approved commercial medicinal products and Sponsors of clinical trials.
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For successful regulatory outcomes, we provide quality medical writing services for clinical trial documents, safety updates, and marketing applications.
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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
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Manufacture high-quality products with streamlined compliance.
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Discover how a collaborative approach to medical writing ensures the highest standards of excellence and precision in every document produced.
WHITE PAPERS AND CASE STUDIES
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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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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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Vial Fogging: Practical Considerations For Vial Selection
Vial fogging is a common phenomenon observed in lyophilized biologic drug products. This document presents two case studies that explore critical factors contributing to vial fogging and inform vial selection decisions.
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Best Practices For Internal Quality Audits In Life Sciences
Discover 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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BioIVT Collaborates With IDBS To Deploy IDBS E-WorkBook And Reduce Study Cycle Times
Learn about a collaboration that has enabled BioIVT to enhance efficiency and responsiveness to its biopharmaceutical clients.
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Richter BioLogics Drives Efficiency And Compliance With Unified Quality
Learn how one CDMO tripled production, improved audit readiness, and built customer trust by unifying quality systems and embracing a digital-first approach.
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The Future Of Regulatory Operations
The pathway to enhancing reliability, compliance, and efficiency across lifecycle management will require embracing technology and process improvement if organizations want to achieve their goals.
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Overcoming The Top 3 Challenges In Setting Up And Managing Clinical Trials
Navigating the intricacies of clinical trials demands adept handling of document management, regulatory compliance, and financial forecasting. Learn key strategies for overcoming these hurdles.
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How To Get Products To Patients Faster With A Connected QMS
BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.
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Building A Legacy In Sterile Injectables Through Strong CMO Synergy
Examine how a CMO can deliver significant value to drug developers by fostering successful outsourcing relationships, streamlining the path to market, and supporting demands.
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Reducing Risk And Timelines In Cell Line Development
Accelerate your biologic development by adopting faster, more reliable clone selection methods that reduce time and resources while improving the likelihood of identifying stable, high-producing cell lines.
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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.
NEWS
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Orange And Camusat Join Forces To Accelerate The Decarbonization Of Telecoms Infrastructures5/5/2025
Orange and the Camusat Group, a pioneer in accelerating the sustainability of telecom infrastructure, have signed a plan that sets measurable targets for the reduction of CO2eq emissions related to the products and services provided by Camusat.
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BBSI Introduces New HRIS Module: Employee File Cabinet1/5/2026
Barrett Business Services, Inc. (BBSI) (NASDAQ: BBSI), a leading provider of business management solutions and one of the largest professional employer organizations (PEO) in the U.S., today announced the launch of its newest HRIS module within the BBSI Client Portal: Employee File Cabinet, a secure, centralized, and fully integrated digital repository for employee documents.
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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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Canopy And Commure Announce Strategic Partnership To Advance Staff Safety In Healthcare7/10/2025
Canopy, a leader in wearable safety and real-time location systems (RTLS) for healthcare, and Commure, the company behind next-generation AI infrastructure for health systems, today announced a strategic partnership to enhance support for Commure Strongline customers and ensure continued innovation in staff safety.
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WEROCK Rugged Tablets: Now With Extended Range Scanner For Long Distances12/2/2025
WEROCK Technologies GmbH, manufacturer of rugged tablets, mobile data collection devices and industrial computers, is expanding the Rocktab Ultra series with an additional integrated barcode scanner option.