INSIGHTS ON REGULATORY COMPLIANCE
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Challenges In Developing Medical Devices From Animal-Based Biomaterials In China
Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.
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Digital Solutions For Accelerated Innovation
In this webinar, hear how Applied Biosystems AccuSEQ software serves as an advanced digital tool that can help streamline bioanalytical processes and accelerate the delivery of life-changing therapies.
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Data Governance And AI In Pharma: Overcoming Challenges In DACH Region
Gain insights from industry experts on the implications of the EU's AI Act for data governance professionals, ensuring your organization remains compliant while leveraging AI's transformative potential.
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The Critical Role Of Residue Removal In Cleanroom Biosafety Cabinets
Learn about the significance of residue removal, how it is effectively performed in cleanrooms to ensure the compliance of biosafety cabinets, and the impact of proper residue removal.
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Ensure Consistency Across Batches With A Powerful Tool5/19/2025
Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.
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How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization9/20/2024
Explore the key aspects of the harmonization between 21 CFR Part 820 and ISO13485 and guidance regarding how to ensure compliance with the new Quality Management System Regulation (QMSR) standards.
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Rising Sun: The Drug Pricing Environment In Japan Is On The Up3/18/2025
Japan’s recent pharmaceutical pricing reforms present new opportunities for the industry, fostering innovation while aiming to ensure faster access to treatments.
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Cell And Gene Therapy Innovations5/19/2025
This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.
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Recommendations For Successful IND Approval Of RNA-LNP Drugs8/22/2023
The existing regulatory system is ambiguous for RNA therapeutics. Leverage this Investigational New Drug (IND) guide to help accelerate and strengthen the process IND filing of novel nanomedicines.
REGULATORY COMPLIANCE SOLUTIONS
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A lot of companies see quality management as a process that puts the brakes on progress. We’re here to change that. MasterControl QMS software will help you digitize and automate every step of quality management. We’ll help you eliminate the hassles, inefficiencies, and paper of your current system. Then you can get your products to market faster.
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Automated microbial screening system capable of picking up to 3,000 colonies per hour
The QPix® Microbial Colony Picker leverages best-in-class colony picking technology to alleviate bottlenecks and quickly, accurately, and efficiently screen through massive genetic libraries. The easy-to-use, intuitive software guides users through setting up colony picking runs where precision robotics pick the right colonies every time.. In addition to microbial screening, the system automates several sample preparation and plate handling processes such as transfer of bacterial liquid culture and plating on agar.
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Digital document control systems introduce automation into your processes. A digital solution is not only more efficient, it also makes it easier to keep up on regulatory changes and maintain compliance.
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As consumer safety becomes increasingly vital, the analysis of nitrosamine impurities in pharmaceuticals is critical. Classified as probable human carcinogens, nitrosamines pose significant health risks, prompting regulatory bodies like the U.S. Food and Drug Administration (FDA), Health Cananda and the European Food Safety Authority (EFSA) to implement strict guidelines.
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From safety considerations to kid-friendly dosing, we can help you get your pediatric formulation right.