Regulatory Compliance Solutions
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Analytical Sciences
4/27/2022
The Kymanox Analytical Sciences group has professionals with global experience in the pharmaceutical, biotechnology, medical device, and in vitro diagnostic industries. We provide ongoing support for all phases of development, from discovery to post-commercialization. With a comprehensive library of proven templates covering study design through final reporting, we meet required timelines and maximize effectiveness and efficiency.
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Microbiology, Environmental Monitoring, & Personnel Monitoring
4/27/2022
At Kymanox, our risk-based approach to Microbiology, Environmental Monitoring (EM), and Personnel Monitoring (PM) ensures facilities and personnel operate in a state of control — ultimately ensuring patient safety.
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Analytical Method Validation
4/28/2022
Kymanox supports pharmaceutical, biotechnology, medical device, and in vitro diagnostic device manufacturers in the validation of methods according to regulatory guidelines. We ensure phase-appropriate validation characteristics are clear for the intended application.
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Biopharma Manufacturing Process Data Made Simple
9/6/2023
PIMS makes BioPharma manufacturing process data accessible, transferable and meaningful
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Sterility Testing For A Connected Era
5/7/2024
This pump combines state-of-the-art hardware with sophisticated, user-friendly software to offer compliant, paperless documentation and reporting.
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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.
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Medical Device Risk Management
4/28/2022
At Kymanox, we provide risk management solutions for medical device compliance with ISO 14971, Medical Device Directive (MDD) 93/42/EEC, and Medical Device Regulations (MDR). We partner with you and your team to develop strategic solutions to address the specific needs of your product. We provide support throughout the product development life cycle including development of a Risk Management File that incorporates risk analysis, hazard analysis, device monitoring, and more.
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21 CFR Part 11 Pharmaceutical FDA Compliant Software
2/28/2023
Why Implement an FDA 21 CFR Part 11 Pharmaceutical Software System?
Learn from industry practitioners and experts why implementing an FDA 21 CFR Part 11 Software System is so essential. Within a year of 21 CFR Part 11 first going into effect MasterControl introduced the industry's first document management software solution specifically designed to help life sciences organizations comply with FDA regulations, the regulations delineated in 21 CFR Part 11 in particular. MasterControl's solutions streamline and automate GxP processes and facilitate effective management of document control, change control, training control, audits, corrective/preventative action (CAPA), customer complaints, and other quality and business processes, all under a single Web-based platform.
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Pharmacovigilance
5/28/2024
The quality of your drug safety team is of the highest importance. That’s why you need an experienced and committed partner who commands the regulatory landscape with confidence. Our global and scalable safety solutions are designed to be efficient, affordable, and fully compliant, giving you flexibility and peace of mind in a complex clinical environment.
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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.