Insights On Regulatory Compliance
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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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How Modern EQMS Solutions Are Powering Pharma’s Digital Revolution
5/13/2022
If your company isn’t at least planning on implementing an EQMS solution or other advanced digital tools, learn why now is the time to start.
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The Role Of FDA Predicate Rules In 21 CFR Part 11 Compliance
7/8/2022
Explore the relationship between FDA predicate rules and GMP, GLP, GCP, or other requirements applicable to your organization.
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Correlating Stopper Height To Container Closure Integrity
11/21/2023
Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.
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10 Things To Know Before Writing An FDA 483 Response Letter
7/6/2022
Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.
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Solutions For Sustainable Chemistry And Supply Chain
7/31/2023
Examine how a CRDMO committed to delivering innovative solutions can help meet the unique needs and requirements of clients in the pharmaceutical, biotechnology, and other industries.
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Building An Effective CCS For Sterile Filtration
6/20/2023
What are the regulatory expectations for sterile filtration throughout product development, how do these feed into the CSS, and how do end-user and supplier responsibilities support Annex 1 compliance?
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Single-Use Strategies For Uninterrupted Microbial Monitoring
2/22/2024
Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.
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High-Velocity Development: Gene Therapy Vs. Small Molecule
12/26/2023
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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Round 2: Mastering NDA Submission And A Resubmission Rescue Mission
3/2/2023
This biopharmaceutical company had to overcome trial master file (TMF) transfer from a previous licensee, staff turnover, and then a resubmission of its NDA.