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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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DownloadMedical 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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DownloadPharmaLex Overview of Services
We are global provider of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance.
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DownloadBiosimilar Quick Links and Guidelines
Links to Biosimilar guidance by national authority
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DownloadAdvanced 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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DownloadOrphan 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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DownloadBiopharmaceuticals 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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DownloadWriting Capabilities
PharmaLex offers a number of writing services, covering technical writing, regulatory writing, medical writing and scientific writing.
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DownloadChemistry, 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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