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

ProRelix Research

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. 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.

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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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6 Reasons Financial Institutions Are Embracing Risk and Regulation Tactics

Perficient: Drug Development

In the fast-paced realm of finance, the significance of regulatory risk and compliance management practices cannot be overstated. The Role of Regulatory Risk and Compliance 1. Legal Obligations and Regulatory Frameworks It is well-known that financial institutions operate within a complex web of laws and regulations.

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Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA

ProRelix Research

Herbal clinical trials in […] The post Essential Compliance Checklist for Regulations on Herbal Clinical Trials in USA appeared first on ProRelix Research. With the increasing popularity of herbal products for both preventive care and therapeutic intervention, the demand for rigorous scientific validation is stronger than ever.

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AI Regulations for Financial Services: SEC

Perficient: Drug Development

Artificial intelligence (AI) is poised to affect every aspect of the world economy and play a significant role in the global financial system, leading financial regulators around the world to take various steps to address the impact of AI on their areas of responsibility.

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Deletion Vectors in Delta Live Tables: Identifying and Remediating Compliance Risks

Perficient: Drug Development

Our Databricks Practice holds FinOps as a core architectural tenet, but sometimes compliance overrules cost savings. There is a catch once we consider data deletion within the context of regulatory compliance. However; in regulated industries, their default implementation may introduce compliance risks that must be addressed.