Biosimilar Regulatory solution center
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New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
1/15/2025
To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.
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Keep An Eye On These Analytical And Monitoring Trends In 2025
12/20/2024
Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.
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Survey Findings: How Are IDMP Readiness Efforts Progressing?
12/13/2024
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
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Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
12/9/2024
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
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Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
12/9/2024
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
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Continued Process Verification: Driving Consistent Quality In Manufacturing
12/9/2024
Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.
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Guide To PUPSIT And Annex 1 In Aseptic Processing
12/5/2024
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
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Is The BIOSECURE Act The First Real Step Toward Reshoring?
11/22/2024
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
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Integrated Approach In Managing CPV And APQR
11/12/2024
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
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A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS
11/8/2024
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?