Fact Flyers
Fact 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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PharmaLex offers full support along the Validation Lifecycle (VLC) for your New Product Introductions and Technology Transfer projects. Our Validation Professionals are not only validation experts, but process experts. And by this we mean experts in all types of manufacturing processes for all types of dosage forms.
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Place your Pharmacovigilance, and Safety surveillance activities in experienced hands. Whether you need an urgent solution for an unexpected problem or are seeking to outsource end-to-end global and local Pharmacovigilance activities – our knowledgeable experts will be there for you no matter where you are.
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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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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.