Blog & Article
- 7th May 2024
Fact Flyers
Fact Flyer
PharmaLex offers full support along the Commissioning, Qualification and Validation Lifecycle (VLC) for your new or modified facilities, equipment, and systems. Our Commissioning & Qualification (C&Q) professionals are experienced in each deliverable from the C&Q portion of the VLC; i.e. the V-Model, as established by ASTM E2500 and ISPE‘s GAMP 5.
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Meetings with the leadership and review staff of the US Food and Drug Administration (FDA) are one of the most important resources available to sponsors seeking agency approval in the US. PharmaLex recommends holding face-to-face and teleconference meetings with FDA throughout the product development timeline.
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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’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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PharmaLex offers regulatory compliance services that address the new FDA requirements that have been implemented to govern the tobacco and vape industry.
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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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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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Early advice on health economics, reimbursement and market access strategy.