Compliance
PRODUCTS
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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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Providing around-the-clock support, enabled by at least two QPs per assignment, delivering full continuity, and reduced risk.
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The MBAL-0250CSP2 is a passive monolithic microwave integrated circuit (MMIC) 1:2 balun developed by Marki Microwave, designed to operate across an exceptionally wide frequency range of 2 to 50 GHz.
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bioGO® Mobile cleanrooms for radiopharmaceutical preparation and compounding
Discover Germfree’s custom mobile radiopharmaceutical compounding trailer or single module. These all-in-one facilities seamlessly serve individual hospitals or specialty compounding pharmacies
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PHCbi brand's 48.2 cu.ft., refrigerator with 8 adjustable shelves and a forced-air circulation for maximum temperature uniformity at all levels. Unique electronic defrost cycle initiates defrost function automatically, minimizing temperature fluctuation during the process. The temperature control system, with a microprocessor, maintains true temperature at the set level and is unaffected by outside ambient temperature. Audible and flashing LED visual alarms alert the user to the unlikely event of either a high or low temperature status. High performance refrigeration system with reserve cooling capacity assures fast recovery following door openings.
WHITE PAPERS AND CASE STUDIES
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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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Turning New Regulations Into IoT Opportunity: How To Become A Trusted Business Partner
In this edition, learn how a technology vendor recognized a need in the market after new industry regulations were introduced and transformed into a trusted business advisor and broader tech expert.
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Online Total Nitrogen Analysis Of Reverse Osmosis Reject Water Reduces Permit Compliance Expense By $350,000 Annually At Beverage Bottling Plant
Learn how a beverage plant cut its annual Reverse Osmosis reject water hauling volume by 50%. Real-time Total Nitrogen monitoring reduced compliance costs by $350,000 and eliminated discharge penalty risk.
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Case Study: Commercial Metals Company Centralizes AP Processes And Save 55,000 A Year With ImageSilo® When the Director of Shared Services at Commercial Metals Company (CMC) was asked to centralize the accounts payable processes of 40 metal recycling yards scattered across the country, he quickly realized that paper documents were the roots of his AP problems at the yards. By Digitech Systems, Inc.
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X-Ray Inspection For Supplement Safety
Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.
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Liquid Handling Solutions For Bulk Drug Substance Management
How modern containment technologies optimize and streamline bulk drug substance management workflows while ensuring substance integrity and safety.
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TAKE Solutions' Team Announces Conatus Pharmaceuticals The Winner In PharmaReady Best Case Study Contest Recently, TAKE Solutions' PharmaReady team announced Conatus Pharmaceuticals the winner in its best case study contest. Of the numerous award submissions, Conatus won by presenting a detailed look into their search for an eSubmissions solution, including their initial criteria, marketplace comparisons and the end results.
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Pharmaceutical Company Quickly Transitions 28 SKUs To Comply With New Labeling Requirements
A large multi-national pharmaceutical company needed assistance in complying with new Health Canada regulatory requirements for labeling over-the-counter (OTC) products. The project scope required bringing 28 SKUs that varied by dosage form, quantity, primary and secondary packaging, as well as therapeutic area – and each SKU had its own unique packaging demands and timeline to maintain an unaffected retail shelf presence - into compliance with PLL. Read how all 28 SKUs were delivered in accordance with the forecast timelines and the overall project was completed early.
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Virtual Study Yields High Compliance & Retention Rates
Clinical research studies involving repeated patient reported outcome measures (PROs) face several challenges. Patients may fail to complete individual PROs, whether at all or within a specified time (i.e., reduced compliance). Patients may cease participating in a study altogether, dropping out before all study procedures are completed (i.e., reduced retention). Read how an app was used in a study that enrolled 124 patients resulted in the majority of participants in the study being 100% compliant and retained through study end.
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How To Survive An FDA Audit
Understanding the FDA audit process, preparing for it and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.
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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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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.
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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Flint Group Confirms German Ink Ordinance Compliance For Sheetfed Packaging Inks And Sheetfed Water-Based Coatings11/18/2025
Flint Group confirms that its Novasens PRIME series of vegetable oil-based Sheetfed Packaging process inks, bases and speciality inks, as well as Novaset water-based coatings, manufactured in Europe, are compliant with the composition requirements of the 21st Regulation amending the German Consumer Goods Regulation, known as the German Printing Ink Regulation (GIO).
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Recipharm Expands Aseptic Filling Capabilities For Process Development, Pilot Scale And Clinical Supply2/5/2025
Recipharm, a leading global contract development and manufacturing organisation (CDMO), has announced that a new modular sterile filling system specifically tailored for process development, pilot scale and clinical supply, is now fully operational at its state-of-the-art facility in Wasserburg, Germany.
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BlueFletch Pioneers Integration With Microsoft's QR Code + PIN Authentication For Frontline Workers2/25/2025
BlueFletch, a leading provider of secure enterprise mobility solutions, announces its pioneering integration with Microsoft's QR Code + PIN authentication method.
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Evonik Coating Additives Launches First Mass Balanced Products For Coatings And Inks3/12/2025
Evonik Coating Additives introduces its first two mass balanced products, TEGO Wet 270 eCO and TEGO Foamex 812 eCO, providing coating and ink formulators with the same high-performing defoamer and wetting agent properties they expect, but with a reduced carbon footprint.