Regulatory Compliance Solutions
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Drug Product Fill Finish And Formulation Solutions
Formulation and aseptic filling solutions are crucial at every stage of development. Consider a manufacturing partner who can address every challenge on the path from pre-clinical programs to commercialization.
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Out Of Specification (OOS) Software For Life Sciences
8/23/2021
The out-of-specification (OOS) product in the MasterControl Quality Management System (QMS) allows for seamless compliance.
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Axon Digidata 1550B Low-Noise Data Acquisition System Plus HumSilencer
6/20/2023
High-resolution, low-noise digitizer with 50/60 Hz line-frequency noise elimination.
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FDA-Registered Detergents
10/7/2020
All Alconox Inc. detergents are Class I Medical Devices and listed as FDA-registered detergents. The list of the detergents is found on the FDA website with FDA Registration number 2410887. Alconox Inc. is also proud to be ISO9001:2015 and ISO13485:2016 Certified.
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SCIEX M5 MicroLC System
9/6/2023
See More with Microflow LC-MS
The M5 MicroLC system is the perfect balance of sensitivity and robustness—more sensitive than traditional analytical flow LC, and more flexible and more robust than nanoflow LC — giving you the potential to optimize your critical workflows, today and into the future.
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Increase Employee Retention And Compliance By Investing In Quality Training From Waters
7/14/2022
Learn how to utilize enabling technologies, including instruments, informatics, and chemistry/consumables with our budget-friendly educational services.
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Pharmaceutical Automation And Information Technology Services
12/21/2020
As a company that specializes in troubleshooting complex systems and equipment, especially in regulated industries, we have gained expertise in Automation & Information Technology (IT) systems. These systems are the foundation of the manufacturing equipment and processes we have been commissioning and qualifying for over 20 years. Our teams work to deliver fully functional and compliant, mechanical and automated systems to our clients. Our expertise extends from specification, through implementation and startup, and into true process optimization.
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Cleanrooms And Equipment For 503B Outsourcing Facilities
6/9/2023
Germfree understands the unique challenges associated with 503B sterile drug compounding
Sterile drug compounding involves preparing customized medical formulations to address individual patient needs. Key challenges include guaranteeing medication safety and efficacy, adhering to FDA regulations, and managing suitable environmental conditions during the process. Improper compounding can be hazardous, making compliance with standards like USP <797> and <800> vital. 503B providers must also follow FDA regulations, including cGMPs, for outsourcing facilities.
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Compliance And Validation Services For Waters Informatics Solutions
9/20/2022
We can assist in the development of necessary validation documents, including test protocols, based on current industry thinking and alignment with global regulatory authority expectations.
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Metrology Teams Collaborating With Waters
7/14/2022
Explore how we can collaborate and customize our service types to help reduce your workload, decrease instrument downtime, and maintain quality standards to meet regulatory requirements.