PharmaLex Medical Device Services

medical devices

About

PharmaLex Medical Device Services, part of Cencora, specializes in regulatory and quality management support for the pharmaceutical, biotech, and medical device industries. With over 20 years of experience, they provide comprehensive compliance and regulatory assistance throughout the product lifecycle, from strategic planning and clinical development to regulatory submissions and post-market activities. Their services include regulatory strategy and consulting, quality management system support, clinical development assistance, and post-market services. They also offer training on quality management subsystems and good practices. PharmaLex serves a diverse range of clients, including top pharmaceutical companies and small to medium-sized enterprises, helping them navigate complex regulatory landscapes and ensure compliance. Their team includes former FDA and EMA experts, providing valuable insights and practical experience to support clients effectively.

Technologies

Cloudflare DNS

Keywords

medical devices ivd premarket ra qa compliance quality auditing qms development revision regulatory affairs strategy submissions remediation postmarket surveillance technical files ce marking csv cers employee training organizational design culture transformation quality metrics regulatory intelligence regulatory agency interfacing responses inspection audit readiness ra maintenance services currency conversion trusted payment processor vat in eu domain buying process

Location

01803 District Ave, Burlington, Massachusetts, United States, 01803

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