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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SMARTRISK - Flyer

It is an electronic tool that allows the MAH to identify the risks presented to the quality, safety and function of each excipient in a systematic and structured approach. SMARTRISK follows the same elements to be addressed as the EudraLex guideline from 2015. This ensures that when addressed correctly the company’s excipient risk assessment meets the requirements of the European regulators. It gives a clear overview of what excipients are present in the various formulations and their associated risk relevant to the individual formulation.

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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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Health Economics

Early advice on health economics, reimbursement and market access strategy.

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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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Real World Evidence

In contrast to the controlled and homogeneous setting in RCTs, the real-world setting consists of a broader and more representative patient population, where treatments are not necessarily used in accordance…

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Value Added Medicines

Value Added Medicines developments aim at enhancing well-established, off-patent molecules by optimizing their efficacy, tolerability, or ease of use or even exploring them in new indications.

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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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