Fact Flyers related to Regulatory Affairs and CMC
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Our Drug Substance Service support offers specialized expertise to navigate the complex landscape of regulatory approvals
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We support you in defining and executing optimal strategies for the EU Clinical Trial Regulation implementation
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Our Access Consortium procedure service offers comprehensive support for all five health authorities: Australia (TGA), Canada (HC), Singapore (HSA), Swissmedic (SMC) and UK (MHRA).
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Developing a biosimilar requires a full set of both experience and expertise in terms of manufacturing, development, clinical, regulatory and market access.
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The switch to eCTD 4.0 will require an update to the eCTD tool but could also have an impact on Content Management Systems and will change how applications are reviewed and approved.
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You’ve already invested so much in your life-changing therapy. Don’t leave its success to chance. Lean on deep regulatory expertise throughout your product’s lifecycle to manage global complexity, and strengthen your market approach.
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As an outsourcing and consulting services company, PharmaLex is your strategic partner to meet your goals for worldwide promotional material review and validation for drugs and medical devices. We provide a broad range of services linked to the review of promotional material for international congresses and local compliance. These flexible solutions range from an integrated package of services to adapted adhoc regulatory and technical support. Our goal is to explore innovative approaches and provide relevant advice to ensure you maintain your competitiveness in this complex and changing regulatory environment.
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PharmaLex offers full lifecycle management for the submission process with flexible options for report-level publishing, compilation of major applications (IND, NDA, BLA) and lifecycle maintenance. Our regulatory affairs professionals are experienced in an array of electronic formats, including electronic Common Technical Documents (eCTD), and Structured Product Labeling (SPL).
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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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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.