Articles by: DA

Challenges Transitioning from Paper to Electronic Batch Records: What Pharma Manufacturers Need to Know

The challenges transitioning from paper to electronic batch records are well-documented, yet manufacturers continue to underestimate the scope of what a successful implementation requires. This guide breaks down the operational, regulatory, and technical barriers FDA-regulated manufacturers face during EBR adoption, and provides actionable strategies to reduce risk and accelerate a successful transition. Why Transitioning from

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How Long Does EBR System Validation Take? A Realistic Planning Guide

Article Summary Regulated facilities ask this question constantly: how long does EBR system validation take?  The honest answer is that timeline depends far less on which software you choose and far more on scope, integrations, batch record complexity, approvals, and testing depth.  A simple, single-workflow EBR can validate in weeks. A heavily integrated, multi-site rollout

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A scientist in a lab working at a computer, highlighting the global cost of preclinical drug failure, with over 60% of candidates failing due to toxicity or efficacy issues.

Preclinical vs Nonclinical: The Key Differences in Drug Development

Knowing the difference between preclinical and nonclinical studies can make a big impact. It helps drug developers plan smarter programs, explain their work more clearly to the FDA, and use time and money more wisely. This guide explains everything you need to know about preclinical vs nonclinical studies in pharmaceutical development. What Does Preclinical Mean?

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Image of a hand interacting with a holographic cloud interface, representing advanced cloud technology with interconnected digital elements on a laptop screen.

What Is Tech Transfer Pharma? A Practical Guide for Pharmaceutical Manufacturers

Pharmaceutical companies lose millions each year when technology transfers fail.  A recent study found that up to 50% of tech transfer projects experience large delays or quality issues during scale-up. Tech transfer pharma processes move products from development labs to commercial manufacturing facilities. When done right, these transfers maintain product quality while meeting regulatory requirements

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Scientists in lab coats handling pill packs with a microscope and lab equipment in the background, focusing on pharmaceutical research.

IND Enabling Studies: A Full Guide to Pharmaceutical Preclinical Development

A recent study by BioPharma Services found that good planning and execution of IND-enabling studies are vital for moving through the drug development process well and increasing the chances of IND approval. The main challenge facing drug companies is the complex coordination needed between pharmacology, toxicology, and regulatory science teams. Your ind enabling studies serve

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A scientist in a lab writing on a clipboard with a flask, conducting research in a professional laboratory setting.

What Is A Target Product Profile? A Full Guide For Pharmaceutical Companies

A recent study by Premier Research found that 24% of late-stage clinical studies fail due to strategic or commercial reasons, rather than operational issues or product safety. The main cause behind these failures is poor coordination between R&D and commercial functions that could have been prevented with proper target product profile development. Your target product

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