Medical Devices for the Pharmaceutical Industry

PharmaLex’s dedicated Medical Device team offers the breadth and depth of expertise to provide comprehensive support throughout the product lifecycle. We employ proven methodologies and hands-on support to optimize
and customize quality and regulatory solutions which are delivered on time, in budget and with the highest quality.

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Medical Device Regulations Transition Support

The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team are available to provide support as required.

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PharmaLex Overview of Services

We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.

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GxP - Operate a functional and efficient Quality Management System

A functional pharmaceutical quality system is not only a regulatory requirement, but also an integral element in pharmaceutical…

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Regulatory Compliance - CMC Implementation

Implementing a sustainable approach to the CMC compliance process. CMC compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors.

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Regulatory Compliance

Pharmaceutical companies are marked by factors such as external changes in the regulatory environment and internal Merger & Acquisition programs, entry into new markets (especially non-ICH regions) or changes…

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Portfolio Maintenance Outsourcing

PharmaLex provides a viable Strategic Outsourcing solution, capable of maintaining your products throughout the life cycle while…

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Medical Information Services

Our extended product portfolio can serve various needs and varies from service models that help to streamline and support internal processes to successful product launch.

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Medical Device Services

Read about our full range of Medical Device services.

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