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NGS is changing GxP compliance. Will you adapt?

BioPharma Drive: Drug Pricing

Discover NGS for GxP compliance with full audit trails, operational control and robust data security.

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. So, yes, compliance and quality still matter, a lot. By John W.M. How will the cuts at FDA impact inspections and enforcement?

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How to Ensure Compliance in Generic Drug Development

Drug Patent Watch

"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.

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Ensuring Regulatory Compliance When Using Wearables in Clinical Trials

Crucial Data Solutions

The post Ensuring Regulatory Compliance When Using Wearables in Clinical Trials appeared first on Crucial Data Solutions. Regulatory Risks of Wearables in Clinical Trials Are Real (and Avoidable) Wearables have become indispensable in modern clinical trials, tracking.

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Easy GxP compliance for NGS data – is it even possible?

BioPharma Drive: Drug Pricing

NGS is changing the landscape for GxP compliance. How can you adapt?

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What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance

thought leadership

Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked in the shadows of compliance.

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A Closer Look at Compliance and Regulations for Drug Clinical Trials in India

ProRelix Research

Once perceived as a regulatory gray zone, the Indian clinical research ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research. The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades.