Insights On Regulatory Compliance
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Why The FDA General Calibration Requirements Are Not Enough
4/10/2024
Calibration is a niche industry that is not well understood by many. By choosing an ISO 17025-accredited organization, companies can benefit from external auditing and adherence to accepted standards.
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EU GMP Annex 1: Impact On Cleaning And Disinfection
3/30/2023
Explore the most recent rewrite of the EU Annex 1 document as well as the contamination control strategy outlined within.
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Gain Support For Your Regulatory Submission Process
3/27/2024
Join us in this video as we delve into invaluable tips, cutting-edge tools, and unwavering support that Cytiva offers to facilitate your documentation progress.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
5/12/2023
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.
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Specializing In Small And Early-Stage Partners, Not Just Small Batches
8/16/2023
Many small and/or early-stage companies are not aware of the need, or the possibility, of finding a CDMO that specializes in meeting their specific requirements.
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Implementing A Risk-Based Approach To Calibration
2/20/2024
Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.
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The Synergistic Role Of Drug Safety In Clinical Trial Operations
4/25/2024
Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.
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Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services
6/26/2024
Gain insight into the mobile cleanroom that was created to accommodate the needs of Moffitt Cancer Center's Oncology Infusion Pharmacy Services and adhere to USP <797> and <800> standards.
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High-Resolution Characterization Of Both sgRNA And Cas9 mRNA
8/8/2023
Improve your characterization of both RNA integrity in the final product and RNA fragmentation with an analytical kit-based solution.
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Navigating The Launch Of ATMPs In Europe
5/29/2024
In 2025, EU's Health Technology Assessment will reshape market access for ATMPs. Proactive planning is crucial for developers to navigate these changes and ensure patient access to innovative therapies.