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Why are Biologics Drugs Different

What is a biologic drug and how does it differ from a traditional small molecule drug? Biologic drugs have increasingly provided for broader therapeutic use over the last few decades and this trend is accelerating. As the first part of…

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Why Hire an Experienced CMC Consultant for Your Early Phase Studies

The simple answer is you save money, time and get an exciting new drug to the clinic for patients. What is Regulatory CMC and why do I need to pay attention to this during development? Regulatory CMC is at the…

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Components of a Successful Regulatory Strategy for Drug Development

Creating a successful regulatory strategy for drug development is important for venturing through the complex landscape of bringing new pharmaceuticals to market. This process makes sure that new drugs meet stringent safety and efficacy standards, making it a critical part…

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The Complete Regulatory Pathway for Medical Devices: From Concept to Market

The complete regulatory pathway for medical devices from concept to market is filled with intricate steps, evaluations, and planning. It’s an essential path for bringing safe and effective medical devices to the public. This process, while complex, is designed to…

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Understanding the Phases of FDA Approval for Drug Development

Navigating the different phases of the regulatory pathway during drug development to achieve FDA approval is a complex and critical process every new drug must undergo. This process, essential for guaranteeing the safety and efficacy of medications, involves a rigorous…

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The Next Generation of Regulatory Submissions: Exploring the Benefits of eCTD 4.0

The eCTD (electronic Common Technical Document) is the standard format the pharmaceutical industry uses to submit regulatory information to agencies worldwide. For the last 20 years, the eCTD has provided the structure to facilitate the review of pharmaceutical products through…

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