2 Industrial Rd Suite 203 Fairfield, NJ 07004

Call: (973) 402-5888

Email: contact@thekentgroup.com

Quality Management System

FDA QMSR regulation compliance audit for medical device manufacturers

FDA’s QMSR Regulation: What Medical Device Companies Must Do Before the Deadline

Th‌e medical d‍evice industry is entering a new regulatory era. Th‌e U.S. Food and D‍rug Ad​min⁠istr‌ation (FDA) has introduced the Quality Man⁠agement System Regulation (QMSR), a major‍ update th‍at change​s h⁠o​w manuf​acturers‌ maintain a‍nd demons​trate comp‍liance. As the FDA QMSR de‍adline appro‍a‍ches,‌ compa⁠ni‍e‍s must understand what the⁠ new requir​ements me⁠an and how they affect existing […]

FDA’s QMSR Regulation: What Medical Device Companies Must Do Before the Deadline Read More »

Pharmaceutical supplier audit team reviewing GMP compliance documents

Pharmaceutical Supplier Audit & GMP Compliance | Chicago, New Jersey & Florida

Pharmaceutical regulation gets stricter every year. cGMP requirements, FDA inspections, and growing expectations around data integrity and supply chain transparency mean drug manufacturers, along with every supplier in their network, face constant scrutiny. For companies sourcing APIs, excipients, packaging, and contract manufacturing services globally, the supplier GMP audit isn’t optional. It’s one of the most

Pharmaceutical Supplier Audit & GMP Compliance | Chicago, New Jersey & Florida Read More »