Compliance
PRODUCTS
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Are you in need of an experienced and flexible GMP service provider that can assist you with the development and clinical manufacturing of your gene or cell therapy with expert CMC support?
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Delve into the details of this full-service global product development and strategic regulatory group that has a proven track record of successful FDA meetings and approvals.
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Configurable readers with triple-mode cuvette ports, validation tools, and compliance software.
The SpectraMax® M Series Multi-Mode Microplate Readers measure UV and visible absorbance, fluorescence, luminescence, fluorescence polarization, TRF and HTRF.
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Aragen with a team of experts converge to offer a diverse range of analytical capabilities. With our flexible service models, including Full-Time Equivalent (FTE) and Fee-for-Service (FFS), we tailor our support to your specific needs.
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Single-Use System
The U2k® single-use centrifuge is the scaled-up version of our successful UniFuge Pilot product. It uses gamma-irradiated, single-use modules to eliminate cleaning needs. It is designed for primary clarification of mammalian cell cultures (e.g., CHO cells) and harvesting (including washing and concentrating) stem cells and other types of cells for biotechnology and pharmaceutical applications.
- Bowl capacity: up to 9 L
- Flow rate up to 20L/min (5 times the flow rate of the UniFuge®.
- Small footprint: 80 cm x 206 cm x 200 cm high (31” x 81” x 78”)
- Easily movable with stainless steel casters leveling on skid with vibration isolators
- Gamma-irradiated single-use modules
- Scale processes down with the UniFuge® Pilot and UFMini®
WHITE PAPERS AND CASE STUDIES
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Case Study: Excavating Company Gains Environmental Compliance For Vehicle Wash Water Brownsville, Penn.-based, Brubacher Excavating, Inc. performs a full range of excavating, pipe and utility installation, roadway construction, general earth moving activities and related site development services in Southeastern Penn. Although the company washes its heavy equipment regularly, its dump trucks and tractors account for the most frequent use of its wash bay.
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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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DeKalb Medical Center Secures Patient Data With Proofpoint As a medical center, DeKalb Medical Center is very sensitive about patient privacy. Recently, the organization conducted an audit of its data security and determined that outbound email was a high-risk area for protected health information (PHI) to leave the enterprise. As a first step, the medical center needed to secure its outbound email stream to ensure that PHI was not being sent out unencrypted. By Proofpoint
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Distribution Of The First Commercial CAR-T Therapy From USA To Japan
Examine the first commercial live shipment of temperature-critical autologous final CAR-T drug product from a USA manufacturing site to a hospital in Japan.
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Developing An Organizational Roadmap For Post Authorization Safety Studies
Delve into this case study to find out how a company found a partner to help them analyze the current state of their pharmacovigilance systems, identify opportunities for improvement, and implement industry best practices and standards.
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Stainless Steel Needles: Quantifying Cobalt Risk For EU Regulation
Learn how a partner who is committed to ensuring the safety of medical devices by mitigating the risk of chemical interaction with drugs is crucial for navigating the regulatory pathway to approval.
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Advancing Compliance And Digital Strategy To Align With Pharma 4.0
AmplifyBio sought to identify areas of its operation where digitalization could yield ROI in a short amount of time. Gain insight into the out-of-the-box solution that aligned with Pharma 4.0.
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Petzl America Ascends To The Next Level Of Distribution Petzl America, a leading distributor of climbing, mountaineering and safety equipment, needed to streamline distribution operations in order to continue to meet customer compliance requirements and changes in order fulfillment characteristics. Submitted by Cornerstone Solutions
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Regulatory Compliance: Weighing In Pharma Manufacturing
Broad regulations, such as GMP, usually leave much to interpretation. This white paper explains which regulations are relevant and how to ensure compliance along the entire weighing product lifecycle.
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Case Study: Allos Faced A Diverse Set Of Business Challenges Allos Therapeutics, Inc. is a biopharmaceutical company focused on developing and commercializing innovative small molecule therapeutics for the treatment of cancer. Allos has 75 employees in offices in Colorado and New Jersey. Especially with distributed employees, a paper-based system was not meeting the company’s needs for information sharing and collaboration. By KnowledgeTree, Inc.
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Fire And Life Safety And Security Industry
New government regulations and the need to update outdated or non-compliant technology are requiring building owners and facilities managers to think about upgrading their fire alarm, security, and fire suppression systems with the latest technology available.
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Eliminating Data Integrity Errors Through Digitization
Explore the urgent need for businesses to adopt strong data integrity practices and identifies measures for how to achieve and sustain compliance.
NEWS
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AERZEN Launches New BABA-Compliant Blowers6/6/2025
Aerzen USA is excited to announce the launch of its new Build America, Buy America (BABA) compliant blowers and controls. These blowers and controls are designed to meet the requirements of the BABA Act and support domestic manufacturing jobs.
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Curia Invests $4M To Enhance Sterile API Manufacturing10/27/2025
Curia, a leading global research, development and manufacturing organization, today announced the completion of a $4M investment to upgrade its two API aseptic suites in Valladolid, Spain.
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Incora's Global Chemicals Business Introduces Use Of RFID Technology To Enhance CMS Offering7/11/2024
Incora, (collectively, “Incora” or the “Company”), a leading global provider of innovative supply chain management solutions, is proud to announce an enhancement to the Company’s Chemical Management Services (CMS) solution offering, incorporating Radio-Frequency Identification (RFID) technology into the Company’s Total Chemical Management Information System (TCMIS).
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Rohde & Schwarz Launches High-Flexibility EMI Test Receivers At EMV2025 Paving The Way For Optimized Investments3/20/2025
The new EMI test receivers R&S EPL1001 up to 1 GHz and R&S EPL1007 up to 7.125 GHz offer engineers a flexible and cost-effective solution for EMI measurements.
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Team UiQ Helps Digitise Health And Safety Compliance1/24/2024
In the contemporary workplace, ensuring the health and safety of employees is not just a regulatory obligation but a cornerstone of sustainable business practice.