Fact Flyers
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Our Affiliate PV solutions help biopharmaceutical companies of all sizes navigate complex regional and local PV regulatory requirements – driving growth in existing as well as new markets worldwide.
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Our quality management and compliance team understands the complexities and demands of the pharmaceutical industry, especially in the Nordic region.
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Many companies face challenges in managing complex trial designs, interpreting diverse datasets, and meeting regulatory expectations – especially in fields like rare diseases and pediatric studies. Navigating this complicated landscape demands deep clinical development experience and knowledge.
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Our SaaS solutions are the outcome of two decades of expertise and development and used by a broad range of biopharmaceutical companies with success. SMARTSTATS is an umbrella software consisting of modules that facilitate report writing in line with regulatory guidelines and authority (EMA/FDA/MHLW/…) expectations.
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Embark on a journey of innovation and excellence with PharmaLex’s Data Strategy and quantitative sciences team. We specialize in delivering comprehensive biometric services tailored to supporting the entire lifecycle of medical product development.
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Chemistry, manufacturing, and controls (CMC) describe critical activities during development and regulatory approval of pharmaceutical and biopharmaceutical products. PharmaLex’s data strategy and statistics dedicated team specializes in leveraging an integrated data-and-analytics approach to accelerate quality throughout the drug development and production lifecycle.
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Experience the power of data-and-analytics seamlessly woven into every phase of your journey, from discovery to market access. At PharmaLex, we redefine possibilities with our innovative approach to data strategy and quantitative sciences.
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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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Our highly professional and experienced IVD & medical devices team, together with our expert biostatisticians, can support you from initial concept development through to formal design and product release.
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We guide you from early strategic planning activities through product development, regulatory submission processes and post-approval / maintenance / post-launch activities. Our experts use technology-enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.
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PharmaLex brings a global reputation for excellence and trust built on decades of experience in quality, regulatory affairs and strategic consulting services. We are leaders in IVD global regulatory compliance.