Regulatory
-
Selecting Container Closure Components: Extractables And Leachables
Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.
-
Attracting The Right Capital — Forming Partnerships For Long-Term Success
5/3/2021
Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.
-
Navigating Regulatory Expectations For Injectable Packaging
12/4/2025
Explore insights on extractables, focusing on how they relate to the revised EU GMP Annex 1, new and evolved expectations under USP <382>, and the use of VHP decontamination in aseptic environments.
-
Navigating Special Regulatory Pathways For Advanced Therapy Development Success
6/12/2025
Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.
-
Simplifying Bioprocess Data Collection
2/17/2023
Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.
-
Faciliflex Cleanroom Module For Therapeutic Drug Manufacturing
1/4/2021
The Faciliflex Module is a transformational new concept in designing cleanrooms for the production of lifesaving therapeutics.
-
The Impact Of Water Activity Testing On Tablets And Capsules
Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.
-
Compressed Gas Risk Assessment: A Significant Step In Your CCS
10/10/2024
Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.