His areas of experience include handling complex quality control operations, regulatory compliance, and leadership of large ...

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

CHENNAI: Lakshmanan (name changed), a sexagenarian, who regularly gets medicines for his neurological condition from the ...

Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has successfully passed the GMP ...

along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby modules covering various aspects of the company’s products are submitted ...

Evolving regulations and market requirements have kept medtech companies on their toes for years. EU MDR, for example, has ...

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities ... containing "observations" that FDA inspectors "deem to be objectionable." ...

Yoda Therapeutics Inc. (YODA), an AI-driven company that focuses on Central Nervous System (CNS) drugs, today announced the dosing of the first patient in the Phase 2 trial of YA-101 for Multiple ...

Pharmaceutical warehousing is not just about storing products; it’s a critical part of the supply chain that ensures the ...