RADIOPHARMA-EXPERTISE @PHARMALEX

Radiopharmaceuticals in diagnostics and therapy form a special product group with specific regulatory requirements in terms of production, distribution, and radiation protection. Necessary safety precautions and often very short half-lives pose special challenges for the business and require a different conceptual approach compared to „conventional“ medicinal products.

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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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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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Chemistry, Manufacturing and Control (CMC)

Our CMC group provides regulatory guidance in setting specifications, method development and validation of documentation. We can help you build a positive relationship with…

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Biosimilar Quick Links and Guidelines

Links to Biosimilar guidance by national authority

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ATMP Quick Links and Guidelines

Links to ATMP guidance by national authority

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Medical Device Services

Read about our full range of Medical Device services.

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Writing Capabilities

PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.

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Orphan Medicine Development

Orphan medicines are intended to treat rare diseases. Both, the EU and US drug legislation have financial and regulatory incentive systems in place to…

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Advanced Therapies - Navigating through the Regulatory Framework

The ATMP regulatory framework in the EU and the US framework programs for cell-based or gene therapy products are complex…

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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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Biopharmaceuticals CMC

Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the…

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