Document Migration
PRODUCTS
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Patient safety is critical for regulatory success. SeQure Dx specializes in off-target analysis services to reduce risk and improve the safety profile of gene-edited cell and gene therapies. Our advanced assays ensure precise editing confirmation and thorough risk assessment across viral and non-viral editing platforms.
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With three clinical pharmacology units, access to 145,000+ hepatic/renal patients, and 100+ completed studies, we’re your partner for NDA-enabling trials.
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Navigating the complex landscape of scientific and regulatory affairs is a challenge for biotech companies. That's why our team is committed to providing solutions tailored to meet these unique needs.
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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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Referenced in the new USP <1207> Chapter Guidance as a deterministic test method for container closure integrity testing.
WHITE PAPERS AND CASE STUDIES
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Multiple Fill Line Delivery Experience
Learn how a multinational pharmaceutical company successfully implemented a global strategy for insulin cartridge filling, achieving seamless regulatory approval with zero deviations.
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Maximize Output From Full-Time Employees
Learn about project-based insourcing solutions designed to give clients laboratory services support with flexible timeframes, and eliminate worries about co-employment and other regulatory concerns.
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Patient Diversity: Identifying Challenges, Opportunities, And Best Practices
By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.
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Digital Biomanufacturing, Now: From Digital Dreamer To Digital Doer
Discover how digital biomanufacturing is revolutionizing drug production by exploring strategies for integrating digital technologies to enhance efficiency and innovation in bioprocessing workflows.
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From CLD To CDMO: Demonstrating A Successful Cell Line Technology Transfer
Explore critical considerations for biopharmaceutical developers and CDMOs during technology transfer as well as a successful transfer and scale-up of a cell line from a CLD platform to a global CDMO.
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How Sharp Packaging's Clinical Packaging Process Is 30% Faster
Discover how digitized workflows and real-time verification are helping streamline clinical trial packaging, reduce complexity, and improve quality in a high-stakes, time-sensitive environment.
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AI Implementation To Enhance Quality
Discover how solutions driven by artificial intelligence can enhance compliance, optimize workflows, and drive efficiency in biopharma operations.
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Why An Integrated Approach Ensures Smooth Entry Into The European Market
Simplify your EU launch and boost returns. Learn how to manage regulatory hurdles, access a huge patient population, and gain end-to-end commercial support.
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Biometric Services For Large Pharmaceutical Company
This case exemplifies the effectiveness of flexible staffing solutions in meeting the dynamic needs of the biopharmaceutical industry while maintaining control over project deliverables and timelines.
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Standardize Flow Cytometry Data With Easy Assay Transfer Across Sites
Gain insight into how a global pharmaceutical company successfully transferred their cell therapy assays across international locations.
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Organizational Assessment For A Large MedTech Company
Explore an organizational assessment run for a medical technology company specializing in tissue repair and regeneration, and the actionable recommendations provided to facilitate future growth.
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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.
NEWS
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Bluebeam Launches Task Link And Mobile Upgrades To Bring Connected Field Intelligence To Construction Teams12/9/2025
Bluebeam, a leading developer of solutions and services for architecture, engineering and construction professionals worldwide and part of the Nemetschek Group, today announced major updates designed to unify office and field teams.
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FileCenter 12 Introduces Two-Factor Authentication And Dark Mode To Enhance Document Security For Small Businesses9/23/2025
FileCenter, the leading document management software for small and medium-sized businesses, today announced the release of FileCenter 12, featuring significant security enhancements, user experience improvements, and advanced document processing capabilities.
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PointFire Search Summarizer Enhances SharePoint Search With AI-Powered Query-Based Summaries3/11/2025
PointFire Search Summarizer continues to transform SharePoint search by delivering AI-generated summaries of SharePoint search results, based on search queries, enabling users to find relevant information faster and more efficiently.
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Viventium And Simitree Partner To Uncomplicate Payroll And Strengthen Workforce Retention For Home Health, Hospice, And ABA Providers12/18/2025
Viventium, a leading provider of cloud-based payroll and HR solutions purpose-built exclusively for healthcare providers, today announced a strategic partnership with SimiTree, a premier healthcare consulting and talent solutions firm.
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RF Controls And Wachter Announce Partnership To Deliver Seamless, Enterprise-Scale UHF RFID RTLS Deployments Nationwide1/11/2026
RF Controls LLC, a global leader in overhead, passive UHF RFID Real-Time Location Systems (RTLS), and Wachter, Inc., a nationwide technology solutions integrator, today announced a strategic partnership enabling the turnkey deployment and upgrade of RF Controls’ Bi-Directional Electronically Steerable Phased-Array UHF RFID Smart Antenna systems across enterprise environments.