Quality

How Will Fortrea’s Latest Acquisition Impact Your Clinical Trials?
Management & Regulatory How Will Fortrea’s Latest Acquisition Impact Your Clinical Trials?

Phase I Pharmacokinetic studies cannot reach their primary endpoints until bioanalytical data is confirmed as valid across the newly integrated organizational framework. The clinical research landscape shifted significantly with the announcement of Fortrea’s acquisition of Worldwide Clinical

Piramal Pharma Highlights ESG Success in New Sustainability Report
Management & Regulatory Piramal Pharma Highlights ESG Success in New Sustainability Report

Piramal Pharma is currently evaluating 38% of its critical suppliers against strict environmental, social, and governance criteria to ensure sustainability throughout the entire value chain. This initiative represents a fundamental shift in how the pharmaceutical industry approaches procurement,

Gland Pharma Hits Regulatory and Financial Milestones
Management & Regulatory Gland Pharma Hits Regulatory and Financial Milestones

Gland Pharma's Visakhapatnam Special Economic Zone Sterile Oncology Facility recently achieved a No Action Indicated status following a USFDA inspection with zero Form 483 observations. This significant regulatory outcome underscores the firm’s commitment to maintaining the highest quality

How Is COFEPRIS Digitizing Medical Device Regulation?
Management & Regulatory How Is COFEPRIS Digitizing Medical Device Regulation?

This digital initiative addresses long-standing inefficiencies by providing a public mechanism to verify the legal status of medical devices sold throughout the country. For many years, the Mexican medical device market struggled with a lack of transparency, where paper-based records led to

How Is Global Pharmaceutical Quality Maintained at Scale?
Management & Regulatory How Is Global Pharmaceutical Quality Maintained at Scale?

Maintaining medicinal consistency across a global network requires navigating a labyrinth of geopolitical shifts and varying international regulatory expectations. The journey of a pharmaceutical product from a manufacturing plant to a patient’s local pharmacy is an intricate operation governed by

Is H5N1 in Fetal Bovine Serum a New Lab Biosafety Risk?
Biotech & Bioprocessing Is H5N1 in Fetal Bovine Serum a New Lab Biosafety Risk?

Laboratories specializing in virology and immunology must now evaluate if their current biosafety margins are sufficient to protect staff from aerosolized H5N1 exposure. The recent isolation of live, infectious H5N1 avian influenza from a commercial batch of fetal bovine serum (FBS) has sparked a

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