Development Consulting, Regulatory Affairs Consulting, Quality Management and Compliance, Pharmacovigilance to the Biopharma, Pharma and Medical Device Industries.

PharmaLex offers a comprehensive suite of services tailored to the pharmaceutical, biotech, and medical device industries, focusing on integrated product development (IPD) and regulatory compliance. Their IPD approach emphasizes a holistic "bench-to-bedside" strategy, which aims to enhance the probability of regulatory approval and successful commercialization of new therapies. By leveraging extensive global product development experience, PharmaLex guides clients through the complexities of drug and medical device development, ensuring that all key functional areas—such as clinical, regulatory, and quality management—are effectively integrated. This strategic partnership model not only optimizes decision-making and program execution but also minimizes risks and costs associated with product development.

In the MedTech sector, PharmaLex provides specialized services to navigate the evolving regulatory landscape, particularly in compliance with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Their expertise encompasses a wide range of medical products, including medical devices, software as a medical device, and companion diagnostics. PharmaLex's MedTech team conducts thorough gap analyses, supports quality management system implementations, and assists with clinical evaluations and technical documentation to ensure compliance with stringent regulatory requirements. By offering tailored solutions and strategic guidance, PharmaLex positions itself as a vital partner for companies aiming to succeed in the competitive and highly regulated medical technology market.

United States

PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world

PharmaLex adds to Cencora's expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle.

Learn more at http://www.pharmalex.com

PharmaLex

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