Insights On Regulatory Compliance
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Modified Release Formulations: Extending Drug Commercial Lifecycle
3/1/2024
A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.
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The Future Of The FDA: Operating In An “Electronic World”
7/6/2022
Explore the FDA's e-transformation that promises to usher in a new era of electronic interactions between the agency and its constituents.
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Assess Your Digital Pharmaceutical Manufacturing Maturity
5/18/2023
Learn how regulated product manufacturers are meeting the demand for faster development and delivery of products to patients and where your operations fit in the digital maturity manufacturing model.
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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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Why You Need A Document Management System In Life Sciences
8/25/2022
In this blog we highlight the history and purpose of a document management system and look into the future with cloud-based electronic document software.
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Biotech Files NDA Following Risk-Based Mock Inspection
6/14/2023
See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.
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Bringing A Culture Of Innovation To Cell Line Development
8/1/2023
To optimize and standardize cell line development that benefits downstream work, organizations must focus on technology and expertise in three key areas: automation, analytics, and digitalization.
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Tapping Into The Unexplored Through 505(b)(2) Pathway
10/9/2023
Leveraging the the 505(b)(2) regulatory pathway can enable an accelerated approval timeline and help advance your drug product to market. Review the three statutes that govern the approval pathways.
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How To Improve CAPA Metrics
10/13/2022
A CAPA management system can provide your company with the ability to recognize and correct risks. Learn how to ensure your CAPA management system benefits the manufacturing process.
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Bioproduction Analytics To Support Optimized Media Development
9/12/2023
Designing and optimizing a cell culture medium can be a complex and time-consuming process, and accurate analytics are vital in streamlining media development to achieve long-term success.