Biosimilar Regulatory solution center
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
7/25/2024
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon
7/11/2024
The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.
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How Recent Trends Impact Bringing Your Molecule To Market
7/9/2024
With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
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A Practical Packaging Components Checklist For Emerging Biotechs
6/20/2024
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations in selection components for your injectable drug product.
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Lifecycle Planning For Containment And Delivery Of Biologics Drug Products
6/20/2024
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.
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What Does FDA's Draft Platform Guidance Mean For CGT Companies?
6/17/2024
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
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Revolutionizing Drug Discovery: The Rise Of Fashionable Models
6/6/2024
As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.
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AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance
6/4/2024
This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.
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Is Your Intellectual Property Safe With Indian CROs And CDMOs?
6/3/2024
Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.