Regulatory Compliance Solutions
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Manufacturing Excellence For Life Sciences
10/19/2023
Learn about Honeywell Manufacturing Excellence, a powerful platform built to accelerate innovation in life sciences manufacturing.
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Cleanroom Capabilities And Expertise
Learn how the right partner can ensure that your facilities maintain cGMP-compliance and help establish the correct testing program and parameters based on your needs.
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Instrument For Accurate Filter Integrity Testing
3/10/2022
The Palltronic Flowstar V integrity test instrument ensures accurate filter integrity testing with a further reduction in test time, full compliance with 21 CFR Part 11, advanced automation capabilities, and simplified network integration saving the user time while improving process efficiency.
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Quality, Compliance, And Regulatory Services For Life Sciences
12/21/2020
The biotechnology, medical device, and pharmaceutical industries are highly regulated globally by a diverse group of agencies. Assuring GMP Quality and Regulatory Compliance throughout your supply chain is a challenge. Meeting this challenge requires a successful interaction between knowledge, systems, and people.
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Regulatory Information Management System (RIMS) Software
8/23/2021
A clear path to global regulatory submissions.
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Class 2 Biological Safety Cabinet: Type B2
8/29/2023
The Class 2, Type B2 Laminar Flow Biosafety Cabinet provides a high degree of localized protection from particulate and aerosol hazards. The work area is continuously bathed with laminar flow ISO 5/Class 100 HEPA-filtered air while creating a negative pressure airflow into the cabinet to provide user protection.
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Quality Auditing
4/27/2022
The Kymanox Audit Team consists of Certified Auditors and seasoned Subject Matter Experts (SMEs) across a wide variety of disciplines with extensive expertise in preparing your company for regulatory body inspections and performing internal audits, external audits, gap assessments, and due diligence evaluations. We manage and execute CMC, clinical, laboratory, and supply chain audits around the world, including support for Pre-Approval Inspection (PAI) readiness.
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Cleanrooms And Equipment For Viral Vector Drug Manufacturing
6/9/2023
Viral vector manufacturing: key to successful gene therapy
Viral vector manufacturing, critical to the burgeoning field of gene therapy, is revolutionizing medicine with its rapid growth and significant potential for treating genetic disorders. By adhering to stringent cleanroom requirements, including BSL-2 standards, Germfree enables the safe and efficient production of viral vectors like AAV and lentivirus. Our specialized cleanroom solutions support the continued advancement of this vital therapeutic field, shaping the future of healthcare worldwide.
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Quantitative Analysis With The SCIEX Triple Quadâ„¢ 5500+ System
6/19/2023
The SCIEX Triple Quad™ 5500+ system is engineered to deliver best-in-class quantitative analysis.
The best just got better. The SCIEX Triple Quad™ 5500+ system is equipped to conquer your laboratory’s most complex workflows and opportunities. With this LC-MS/MS system, you have the sensitivity and performance to meet analytical and regulatory demands for low-level trace detection with ease.
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Single-Use Supply Chain: The Distinct Advantage Of The Advanced Central Management System (ACMS)
6/6/2022
This fully validated solution to support a Quality by Design approach to single-use assembly design and production. It ensures the delivery of high-quality, fit-for-purpose, single-use systems with strong documentation packages.