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Azzur Group

A nationwide network of experts delivering professional services across the life sciences industry, Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest growing private companies in America, Azzur Group provides clients with the consulting, facility solutions, engineering, validation, IT, technical, training, and laboratory services and solutions they need to remain innovative and competitive. Website: https://www.azzur.com/
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Ellab

Since 1949, Ellab is a leading manufacturer of a full line of wireless, real-time data loggers and wired thermocouple validation systems with temperature, humidity, pressure, vacuum, conductivity and CO2 sensor options. Additionally, Ellab offers temperature standards, calibration dry blocks and liquid baths, custom fittings, accessories, and thermocouples. We also offer on-site qualification, validation and calibration services for thermal validation processes ranging from -196°C to 400°C. Typical environments often include -80°C freezers, incubators, stability chambers, autoclaves, and ovens. Website: https://www.ellab.com/
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CAI

Fundamentally we exist for one reason: To accelerate our clients’ path to success. Our approach is simple; we put the client’s interests first. We don’t stop until it’s right. And we’ll do whatever it takes to get there. Website: https://commissioningagents.com
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Kaye

For almost sixty years, Kaye has been at the forefront of high accuracy process measurement. For applications from thermal process validation and environmental monitoring, to sensor calibration, Kaye technology has provided the most accurate and user friendly measuring systems available in the market today. Website: https://www.kayeinstruments.com/en/
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Aventior

Aventior (www.aventior.ai) is an AI and Data Science company that is building data management and process automation solutions for the life sciences industry. Its CPV Automation (“CPV Auto”) platform uses AI-assisted technologies to process batch records that are either printed, scanned or hand-written. Through this automation, Aventior has reduced document processing times by over 75%. Some of the leading biotech firms use this platform to reduce their dependency on manual effort, decrease their data collection efforts, reduce errors and reduce the time to stay FDA compliant. Website: www.aventior.ai
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CIMCON Software

CIMINFO’s LabMonitor software brings legacy lab applications into Part 11 compliance. Other solutions include Part 11 controls for Spreadsheets, Document and Quality Management, Training and an Inventory System for data integrity assessments. With over 20 year of experience, CIMINFO products are trusted by hundreds of FDA-regulated firms in over 30 countries. Website: https://part11solutions.com/
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H&A Scientific

H&A Scientific, Inc. is a scientific software development firm specializing in pharmaceutical industry support. We develop, validate, and market quality computing systems for scientific data acquisition, processing, and data management. We have been creating programs for the laboratory since 1992. Our products have been designed under our Quality System to adhere to the current GAMP guidelines. We develop Quality Software products based on the needs of pharmaceutical companies subject to the constraints and compliance of the Food and Drug Administration (FDA). Our flagship product, SLIM, is a commercial off-the-shelf solution for total management of a company's drug stability program. Website: http://www.hascientific.com/en/
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Lighthouse Worldwide Solutions

Founded in 1982, Lighthouse Worldwide Solutions is the world’s leading manufacturer and supplier of real-time air, liquid, gas and microbial contamination monitoring systems and particle counters. Our company has leveraged superior software design, data integration ability and worldwide support offices to provide our customers with leading edge environmental monitoring solutions. These solutions have positioned Lighthouse’s customers to enhance their risk mitigation and regulatory compliance systems and procedures, as well as to help ensure the high level of quality control required to increase product yields through continuously monitoring conditions that may have an adverse impact on their products. Website: http://www.golighthouse.com/
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Novatek International

Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries. Our unique portfolio of out-of-the-box, easy to use software solutions features specialized modules that help you manage all aspects of your quality environment with less effort and time. Novatek delivers solutions that go beyond LIMS for total enterprise wide automation. Website: https://ntint.com/
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PharmaLex

PharmaLex is one of the largest providers of Quality and Validation Services, Regulatory Affairs, Development Consulting and Pharmacovigilance & Risk Management worldwide. Our teams of experts offer a comprehensive portfolio of regulatory compliance services to support pharmaceutical, biopharmaceutical, and medical device organizations throughout the entire product lifecycle. Website: https://www.pharmalex.com/
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QACV

QACV offers comprehensive quality assurance, compliance, and computer validation consulting services to meet your regulatory needs. We provide professional consulting services to FDA regulated life science industries and use proven methodologies to achieve sustainable compliance for your organization. Website: http://www.qacvconsulting.com/

135 E Kings Highway
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Email: info@kenx.org
Phone: 858 649 3251

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