Compliance
PRODUCTS
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The robotic capsule filler, part of the Explore Range, integrates our award-winning Fill2Weight technology, eliminating ‘formulation for filling’ steps and reducing pre-clinical timescales, fast tracking to Phase III.
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Natoli Scientific’s preclinical stability studies represent a critical facet of our pharmaceutical testing services, providing essential data on the shelf life and storage conditions of drug candidates. These studies are expertly designed to evaluate physical, chemical, and microbiological stability, ensuring that formulations retain their safety, efficacy, and quality over time. Our state-of-the-art facilities simulate various environmental conditions to scrutinize the integrity of products under stress-testing scenarios. The results gleaned from our stability studies guide the development of robust drug formulations and packaging, aid in regulatory submissions, and lay the groundwork for successful commercialization.
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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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Gain access to Culture bioreactors when you need rapid overflow experimental capacity.
Benefits
Progress studies faster
Run overflow projects and conduct parallel experiments with Culture to reduce time and alleviate bottlenecks.
Stay agile in your capacity planning
Scale your workload at Culture according to your current needs. Respond rapidly to surging demands.
Eliminate your capital equipment spend
Leverage Culture’s facility quickly to avoid building out lab space, spending capital on equipment, and hiring specialized staff.
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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.
WHITE PAPERS AND CASE STUDIES
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Accelerated Development Of Solid Oral Dosage Formulation For IND Submission
This paper highlights how the roller compaction process not only enhances efficiency but also improves the scalability of solid oral dosage production, supporting rapid development for regulatory approval.
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Bausch & Lomb: Implementing A Global 21 CFR Part 11 Compliant CAPA System When Peter J. Mueller, Manager of Global Quality Information Systems selected a global CAPA (Corrective and Preventive Action) system for his company, he knew exactly what he was looking for...
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Osmolality: A Powerful Tool In Bioprocessing
Learn more about the broad range of applications for osmolality testing and why it is crucial for process development, analytical development, and GMP testing.
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Successfully Shipping Life-Saving Treatments For Humanitarian Aid In Ukraine
As part of a humanitarian effort responding to the ongoing crisis in Ukraine, shipping critical compassionate use medicinal products and supplies had several challenges to overcome.
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Q&A: Payment Processing With Precidia Technologies Precidia has issued several press releases, through late 2008 and early 2009 regarding the TransNet solution. What is your strategy with this product? In introducing TransNet, we are offering the market an alternative to the established integrated payment model. Our solution addresses some of the limitations of the...
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Graniterock Speeds Up Reporting From 7 Days To Real Time
Graniterock is one of California's premier construction materials producer, delivering hot mix asphalt, recycled asphalt, concrete and other materials to roads, highways, runways and bridges from San Francisco to Monterey. Safety is a core value at Graniterock, and the company requires employees to adhere to safe work practices at all times. The company wanted to update its slow, paper-based process for equipment and safety inspections to a more efficient solution based on mobile devices and cloud-connected services.
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Focus On Your Core Business Strategy
Learn how a large manufacturing client helped to focus on their core business with a solution that transitioned approximately 60% of the workforce and capitalized on the initial training investment.
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How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency
With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.
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Utility Companies Prepare for the Year 2000 Companies across the nation are working on Y2K compliance programs to prepare for 12:00 a.m. on Jan. 1, 2000...
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24/7 Cell & Gene Control Tower Provides Agile Solution For Critical Shipments
Get an overview of a successful re-route of six critical shipments to the UK and Spain from Amsterdam used to deliver CAR-T drug products to treat non-Hodgkin’s lymphoma cancer patients.
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Navigating Regulatory Compliance In Medical Device Development For Prefilled Syringes And Auto-Injectors
Developing prefilled syringes and auto-injectors requires rigorous mechanical, user-focused, and compliance testing to ensure device safety, effectiveness, and seamless regulatory approval for patient use.
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Operationalizing Disclosure Intelligence For Go-To-Market Success
Regulatory intelligence goes beyond ensuring compliance. By monitoring and understanding these integral disclosure obligations, sponsors can position clinical trials for seamless completion from the start, and position themselves as industry leaders.
NEWS
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AppTec360's Advanced Mobile Content Management Solutions Reinforce Enterprise Security3/11/2025
Data security remains a critical concern for organizations as the risk of breaches and unauthorized information sharing continues to rise. Addressing these challenges, AppTec360 introduces ContentBox, a Mobile Content Management (MCM) solution designed to enhance security while enabling seamless file synchronization and controlled data access.
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SecEdge Unveils Embedded TPM For NXP i.MX 6, 7, 8 And 9 Series Applications Processors11/19/2025
SecEdge, a leader in digital security for edge devices, today announced the availability of its SEC-TPM foundational device security solution for NXP Semiconductors i.MX 6, 7, 8 and 9 series of applications processors.
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New Automated Cybersecurity Testing For Embedded Software Available In Compliance With RED EN18031 Standard7/23/2025
Starting in August of this year, connected digital products will be required to comply with the EU Directive RED (Radio Equipment Directive) EN 18031. In response, Düsseldorf-based cybersecurity company ONEKEY has integrated testing for RED EN 18031-1 into its automated cybersecurity platform.
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u-blox Launches SIG 2.00 GNSS Firmware: 95%-Confidence Geolocation For Wi-Fi 6E/7/8 Access Points12/11/2025
u-blox, a global leader in positioning and short-range communication technologies for automotive, industrial and consumer markets, today announced the release of Standard Infrastructure GNSS (SIG) 2.00, a dedicated GNSS firmware solution for Wi-Fi 6E/7/8 access points operating in the 6 GHz band.
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Cade & Associates Launch Managed Human Resource Services2/12/2025
Cade & Associates is proud to announce the launch of its Managed Human Resource Services, a comprehensive solution designed to simplify HR management for businesses of all sizes.