Transactional Content Management
PRODUCTS
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Reduce manual validation efforts, cut costs by up to 30%, get new products out the door faster, and enable seamless regulatory inspections.
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Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.
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Global Strategies to Align Your Goals With Regulatory Requirements
Ergomed’s regulatory consultancy services are guided by a team of seasoned consultants, each bringing a wealth of experience from regulatory agencies and in-house roles. This expertise ensures a proactive and flexible solution tailored to your project’s unique needs and timelines, instilling confidence in our services.
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In the ever-evolving landscape of life science manufacturing, risk management is paramount to ensuring product quality, compliance, and timely market delivery. Meet MasterControl's Quality Excellence — your gateway to comprehensive and efficient quality risk management.
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In today’s competitive and capital-constrained cell and gene therapy environment, early decisions around Chemistry, Manufacturing, and Controls (CMC) can make or break a therapy's timeline, cost-efficiency, and eventual approval. Yet many emerging cell therapy companies struggle with CMC strategy until it becomes a bottleneck.
WHITE PAPERS AND CASE STUDIES
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A Digital Solution Embeds Quality Into Cellular Therapeutics Production
Discover how Dendreon cut review and release time by nearly 50% while maintaining a 99% right-first-time rate, which boosts collaboration, visibility, and operational efficiency across teams.
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Partner Case Study: Accelerating Gene Editing Manufacturing
Beam Therapeutics partnered with ElevateBio to manufacture BEAM-101, a novel base editing therapy for sickle cell disease, advancing rapid, high-quality production towards clinical trials.
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Choosing An R&D Data Management Platform For Novel Antibody Therapeutics
Uncover how this collaboration ensured the implementation of a robust electronic system that streamlined R&D operations, increased data integrity, and ultimately supported the development of novel antibody-based therapeutics.
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Pharma Company Digitizes Paper Logbooks To Increase Data Accessibility
A top pharma producer modernized its operations by digitizing paper-based logbooks. Discover how this shift supports compliance and scalability across global manufacturing environments.
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Flexible Fill/Finish Solutions To Bridge The Clinical-To-Commercial Gap
As biopharma complexity grows, flexible CDMOs are essential for navigating evolving fill/finish needs, accelerated timelines, and regulatory uncertainty with agility and expertise.
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FDA Recommendations For Gene Therapy For PMDs
Explore insight into the strategies and FDA recommendations for executing gene therapy development programs, specifically for primary mitochondrial diseases (PMDs).
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University Of Ottawa Relies On The BEAMAGE Series To Measure Laser Profiles
The University of Ottawa lab successfully used beam profilers to improve Power-Over-Fiber receiver chip development, ensuring precise, efficient laser measurements for advanced photonic research.
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Rapid, Seamless Upstream Process Development And Scale-Up For CHO-K1 Cells
Accelerate your biotech company's scale-up process while delivering consistent and strong cell growth, productivity, and product quality.
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Inside A Collaboration To Design Cutting Edge Modular Cleanrooms
Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.
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Putting The Squeeze In Sponge Cities: Amsterdam's Waternet And The Innovative RESILIO Blue-Green Roof Project
The RESILIO project has helped Amsterdam repurpose rooftops as smart blue-green roofs to reuse rainwater and prevent localized flooding. This project, along with other sustainable water initiatives like the Amsterdam Rainproof program, continues to position the Netherlands at the forefront of water management.
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Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration
A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.
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Leading European CDMO For Drug Product Manufacturing
As timelines tighten and regulatory demands grow, discover how a European CDMO delivers integrated solutions from aseptic fill and finish to packaging and release.
NEWS
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Scientists Discover Potential Blood Test For Asthma Diagnosis And Severity9/29/2025
Scientists at Rutgers Health have discovered that a simple blood test could diagnose asthma and determine its severity, a breakthrough that could transform how the disease is identified and monitored.
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Eurofarma Is The First Brazilian Company To Implement Körber's PAS-X MES For Improved Data Access, Traceability, And Regulatory Compliance7/10/2025
Eurofarma Laboratórios has become the first Brazilian company to migrate its entire production at its main plant in Itapevi, São Paulo, to Körber's PAS-X Manufacturing Execution System.
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Plant Adaptation Research Could Help Find Ways To Make Crops More Resilient To Climate Change1/3/2025
A team at the University of Calgary is making scientific advances in understanding plant adaptation, which could ultimately be used to find ways to make agricultural crops more resilient to heat, drought and climate change.
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With Passive Approach, New Chips Reliably Unlock Color Conversion11/14/2025
Over the past several decades, researchers have been making rapid progress in harnessing light to enable all sorts of scientific and industrial applications.
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A New Type Of Light-Controlled Non-Volatile Memory10/9/2025
Ferroic materials, like ferromagnets and ferroelectrics, are central building blocks of modern data storage technology. Yet, current platforms face fundamental limits.